Medtronic 20046 Instructions for Use

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PS Medical® Ventricular Catheters

onstant level

Twist Drill or Burr Hole

Radiopaque

Outlet ports

Radiopaque mark

Radiopaque Pressure Dot

Silicone membrane valve

Silcone dome

Flow Rate (mL/hr)

Pressure (mm H

Outlet

Description

PS Medical® Ventricular Catheters are available in a variety of congurations: small and st andard sizes; di erent lengths; with or without anges; barium imp regnated; tr anslucent or tr anslucent wi th stripe; pli ant; and snap assembly. See package labels for conguration details.

The cath eter has a bulle t-shaped tip  lled with rad iopaque sil icone elasto mer. Black leng th markers ma de of a graphi te-impre gnated silico ne elastome r are positio ned on the cat heter at point s 5, 10, and 15 cm (+/- 0.25 cm) from the prox imal tip to enab le the surgeo n to gauge the dep th of penetr ation of the ca theter into th e lateral vent ricle.

Ventricu lar cathete rs are packag ed with a right a ngle clip (except f or catheter s designed f or use with bur r hole reser voirs and val ves). The right angl e clip packag ed with the cat heter is desig ned to angulat e the catheter t o lie within t he mid-por tion of the late ral ventricl e.

Each of th e catheter s is kink and comp ression resi stant, is imp rinted with le ngth marker s, and is packag ed with a stainl ess steel st ylet inser ted in the lume n. The proxima l end of the cath eter has a single l ine of inlet hol es spaced at 90° intervals around the circumference of the catheter tubing.

PS Medic al®Barium-Impregnated Ventricular Catheter

Barium -Impregna ted Ventricul ar Catheter s are fabrica ted from rela tively rm, ba rium impreg nated silicone elastomer tubing for radiopacity.

PS Medic al®Ventricul ar Catheter with Bi oGlide

The Ventricular Catheter with BioGlide has an interior and exterior hydrophilic surface modification for enhanced lubric ity and ease o f inserti on. It is a nominal 2 3 cm long and is av ailable with a 1.3 m m inner diame ter. The cathet er is fabri cated of tra nslucent sili cone elastom er tubing wi th a radiopaq ue stripe. Re latively f irm tubing is i ncorpora ted in the catheter design to provide resistance to catheter kinking and compression. A right angle clip, designed to angulate t he cathete r at the burr-ho le site witho ut kinking, i s packaged w ith each cath eter. The tip of th e Ventricular Catheter with BioGlide is bullet shaped and is filled with radiopaque, tantalum-impregnated silicone elastomer. Length s are marked in 1 cm i ntervals i n reference to t he proximal t ip, thus enabli ng the surgeo n to gauge the de pth of penetr ation of the c atheter into t he lateral vent ricle. The pr oximal end of t he catheter h as 32 flow hole s—four lines of eight ho les spaced at 9 0° interva ls around the c atheter cir cumferenc e.

A stainl ess steel st ylet, pack aged with eac h catheter, is des igned to faci litate intro duction of t he catheter i nto the lateral ventricle.

PS Medic al®Standard Ventricular Catheters

The Stand ard Ventricul ar Catheter ha s an outer diamet er of 2.5 mm and an inn er diameter of 1.3 m m (dimensions nominal).

PS Medic al®Small Ventricular Catheters

The Small Ven tricular Cat heter has an ou ter diameter of 2.1 mm and a n inner diamet er of 1.2 mm (dimensio ns nominal).

PS Medic al®Translucent Ventricular Catheter

The Translucent Ventricular Catheter is fabricated from translucent, non-radiopaque silicone elastomer tubing.

PS Medic al®Translucen t Ventricular Cath eter with Radio paque Stripe

The Translucent Ventricular Catheter with Radiopaque Stripe is fabricated from translucent silicone elastomer tubing with a radiopaque stripe encased within the tubing wall.

PS Medic al®Slotted Ventricular Catheter

The Slotted Ventricular Catheter is fabricated from barium impregnated silicone elastomer tubing. The catheter is a large si ze with an outer d iameter of 2.8 mm a nd an inner diame ter of 1.5 mm (dimensi ons nominal). Ea ch cathet er has 4 axial cha nnels with 5 hol es in each.

The Slot ted Ventricul ar Catheter ha s enlarged rec tangular  ow holes, whic h optimize the ce rebrospina l fluid (CSF) ow into th e catheter. Rece ssed ow hole s in axial chan nels are design ed to minimize c atheter ow ho le contact with surrounding ventricular walls and intraventricular debris.

PS Medic al®Innervision Ventricular Catheter

The Innervision Ventricular Catheter is fabricated from barium impregnated silicone elastomer tubing in a standa rd diameter. The c atheter has an o uter diamete r of 2.5 mm and an inne r diameter of 1.2 mm (di mensions nominal ). Each cathete r has 4 rows of 8 ow ho les 90° apar t.

The catheter is designed to be used with the NeuroPEN endoscope or an other compatible Medtronic Neurosurgery endosc ope when the phy sician desir es direct vi sion from the t ip of a ventric ular cathete r during its pl acement. Direc t vision faci litates plac ement of the cat heter tip at a spe cic intrave ntricular l ocation. The c atheter is design ed to be used as th e proximal comp onent of a CSF- Flow Control Sh unt for use in shu nting CSF fr om the ventric les of the brai n into the right a trium of the he art or to the per itoneal cav ity.

NOTE: If a Tyve k tip insert is p resent, rem ove it from the c atheter bef ore insert ing endoscop e into cathet er lumen (Fig1).

PS Medica l® Flanged Ventricular Catheter

The Flang ed Ventricula r Catheter, availa ble in the small tubing size only, has eight exible silicone elastomer anges (F ig2) and has 20 inlet h oles positio ned at 90˚ inter vals around the c atheter bet ween the ang es (Fig3).

The ange s are designe d to bend and cove r the inlet holes in the catheter tubing during insertion protecting the inlet holes from obstruction by brain fragments or blood c lots. The an ges resume a n extended conguration upon entering the ventr icle and help p revent dire ct contac t of the inlet h oles with the choroid plexus and ventricle wall.

PS Medic al®Snap Assembly Ventricular Catheter

The Snap Shunt Ventricular Catheter is available separately in several integral ventricular catheter lengths: 3throug h 11 cm.

The Snap Shu nt Ventricula r Catheter is f abricated o f silicone elas tomer and poly propylene, a nd is designed t o be used on ly with a Snap As sembly Rese rvoir Dome. T he kink- and compr ession-re sistant ven tricular cat heter is fabricated with smooth, radiopaque silicone elastomer. The firm polypropylene base contributes to structural integr ity, and reduce s the potentia l for penetra tion by the nee dle during per cutaneous injec tion . A stainless s teel styl et is included w ith the cathe ter. The style t is designed t o facilitate i ntroduct ion of the cath eter into the lat eral ventric les. The cat heter is packa ged with the s tylet inse rted in the lum en.

PS Medic al®Pliant Ventricular Catheter

The Pliant Ventricular Catheter is fabricated from softer (lower durometer) silicone elastomer tubing.

PS Medic al®Ventriculostomy Ventricular Catheter

The Ventriculostomy Ventricular Catheter is fabricated of silicone elastomer and polypropylene, and is designed to be used o nly with a ventr iculostom y reservoir d ome. The kink- an d compressio n-resist ant ventricu lar catheter is fabricated with smooth, radiopaque silicone elastomer. The rm polypropylene base contributes to structural integr ity, and reduce s the potentia l for penetra tion by the nee dle during per cutaneous injec tion .

PS Medic al®Opus®Ventricula r Catheter with Op us® Stylet

PS Medical®Opus® Ventric ular Cathete rs provide th e physician wi th immediate v isualizati on of CSF upon cor rect cathet er placement be fore sty let withdraw al.

Each Opus Ventricular Catheter is packaged with an Op us Stylet in serted in th e lumen designed to facilitate introduction of the cathet er into the late ral ventric le. The Opus Stylet h as a hollow shaf t, an entr y port and an exi t port, per mitting a f ree ow of CSF and visualization during catheter placement (Fig 4a). The Opus St ylet has a molded L uer-lock out let grip arou nd the exit po rt. Flow of CSF t hrough the e xit port may be stop ped by coveri ng the exit po rt with a glov ed nger (Fig 4b). The Lue r-lock outl et grip also all ows attac hment of a syri nge for CSF sa mpling.

CAUTION: DU E TO THE LENGTH OF THE ST YLET SHAFT, CSF FLOW THROUG H THE STYLET SHAF T MAY NOT OCCUR IN PATIENTS WITH LOW INTRACRANIAL PRESSURE.

CAUTION: C ARE SHOULD BE TAKEN TO MINIMI ZE THE AMOUNT OF CSF AL LOWED TO ESCAPE THRO UGH THE OPUS STY LET.

Opus Ventr icular Cath eters are a no minal 23 cm lon g and are availab le in Small and Sta ndard diame ters. All Opu s Ventricular Catheters are fabricated from silicone elastomer tubing impregnated with white barium sulfate to provide radiopacity. Relatively rm tubing is incorporated in the catheter design to provide resistance to catheter kinkin g and compres sion. A right an gle clip is pac kaged with e ach cathete r. The clip is desi gned to angula te the cathet er at the burr-h ole site with out kinkin g. The tip of the O pus Ventricu lar Catheter i s bullet-shap ed and is lled with radiopaque tantalum-impregnated silicone elastomer. Black length markers are positioned on the catheter at 5, 10 and 15 cm from t he proximal t ip to enable the s urgeon to gaug e the depth of p enetratio n of the cathe ter into the lateral ve ntricle. Th e proximal end o f the cathet er has 32 ow holes -four lines of e ight holes sp aced at 90° int ervals around the catheter circumference.

4a 4b

PS Medic al®Rivulet® Ventricular Catheter

The Rivu let Ventricul ar Catheter co ntains vary ing sized and ev enly placed in let holes (Fig5), designed to equalize the distribution of inflowing CSF across all inlets. The equalized inlet flow dynamics reduce s the magnitud e of maximum inl et velocit y vectors co mpared to convent ional cathe ters. The plac ement of the f low holes clos er to the tip, com pared to conve ntional cath eters, allow s for intravent ricular positioning away from the choroid plexus in normalized ventricles.

The Rivulet Ventricular Catheters are fabricated from bariumimpregnated silicone elastomer tubing. The catheters are radiopaque, and are ki nk and compres sion resist ant. They measu re 15 cm (5.9”) in leng th, 0.15 cm (.06”) in inner diam eter, and

0.25 cm (.100”) in o uter diamete r, and contain blac k graphite- impregnate d silicone elas tomer-leng th markers to aid in determining depth of placement.

Indications

Ventricu lar cathete rs are design ed for use as prox imal compon ents of CSF-F low Control Shu nts for use in sh unting cerebro spinal uid f rom the ventri cles of the bra in into the righ t atrium of the h eart or to the pe ritoneal cav ity. The small c atheter is re commended fo r use in patien ts where a small er diameter is in dicated.

Instructions for Use

A variet y of surgica l techniques m ay be used in plac ing the cathe ters into the la teral ventri cle. Site of place ment is at the discretion of the surgeon.

A stainl ess steel st ylet, pack aged with eac h catheter, is des igned to faci litate intro duction of t he catheter i nto the lateral ve ntricle. The c atheter is pa ckaged with t he stylet i nserted in t he lumen. Once th e catheter is p laced into the ventr icle, the st ylet is withd rawn from the c atheter.

The righ t angle clip may b e used to bend th e ventricul ar catheter to a n approxima te 90˚ angle whe re it exits t he twist

Right Angle Clip

Suture Tie

Ventricular Catheter

drill or b urr hole (Fig6). (The cli p must be remov ed when the c atheter is us ed with the B urr Hole Valve). The clip ma y be used as a marker fo r planned dep th of catheter insertion by sliding it the appropriate

distan ce from the pr oximal tip of th e catheter prior to i nsertion ( Fig7); this can be do ne with the st ylet in the cat heter. After t he catheter is prope rly positio ned in the vent ricle, the extr acranial po rtion of the c atheter is p ressed into the sp lit tubular s egment of the c lip to form the right angle bend (Fig8 and Fig9). Avoi d stretc hing the cat heter when it i s pressed int o the clip. If th e catheter is t o be placed in the v entricle throug h a tubular intr oducer, the cli p must be removed prior to insertion of the catheter through the introducer.

It is reco mmended that t he right angl e clip be secu red to adjacen t tissue by pass ing suture s through the t wo suture holes on t he sides of the c lip (Fig6). If the righ t angle clip is no t used, it is re commended t hat the surgeo n trim the rim o f the twi st drill or bu rr hole to prov ide a beveled no tch where the c atheter eme rges and cur ves to lie adjac ent to the skull .

CAUTION: LOW T EAR STRENGTH IS A CHAR ACTERISTIC OF MO ST UNREINFORCED SILICO NE ELASTOMER MATERIALS. C ARE MUST BE TAKEN WITH THE HAND LING AND PLACEMENT OF THE S ILICONE ELASTOM ER CATHETER TUBI NG TO AVOID CUTS, NICKS, OR T EARS.

CAUTION: DU E TO THE LENGTH OF THE ST YLET SHAFT, CSF FLOW THROUG H THE STYLET SHAF T MAY NOT OCCUR IN PATIENTS WITH LOW INTRACRANIAL PRESSURE.

CAUTION: C ARE SHOULD BE TAKEN TO MINIMI ZE THE AMOUNT OF CSF AL LOWED TO ESCAPE THRO UGH THE OPUS STY LET.

tab groove

Burr hole

Bend catheter

push into

Skull

To ventricles

PS Medic al®Ventricul ar Catheter with Bi oGlide

Prior to handling, connection and placement, the Ventricular Catheters with Bio Glide must be f ully hydrate d in sterile, f iltered, iso tonic saline. During submersion, a portion of the hydrating solution is absorbed giving hydrophilic qualities to the surface. An ordinary silicone elastomer catheter has hydrophobic characteristics (Fig10a). The hydr ophilic quali ties of BioGlide Catheters—lubricity and smoothness—are shown in Figure10b. Full hydration is accomplished in a minimum of two minutes. BioGlide Cathet ers are packa ged in trays wi th a built-in wel l to accommodate t he hydrating solution and a channel for catheter submersion (Fig 11).

CAUTION: C ATHETER MUST BE FULLY HYDRATED P RIOR TO REMOVAL FROM TRAY, INSERTION O F STYLET, AND ALL OTHER H ANDLING OPERATIONS. HANDLING WITHOUT FULL HYDRATION COULD DAMAGE THE CATHETER’S HYDROG EL SURFACE.

CAUTION: D O NOT INSERT STYL ET INTO CATHETER LUMEN PRI OR TO FULL HYDRATION.

BioGli de product s are provide d sterile, in a dou ble layer pack aging syste m. Using approp riate techni que, clean, and then o pen the outer po uch, allowing t he sealed inne r tray to fall ont o the sterile f ield. All hydr ation and handlin g of the BioGlid e product s must occur wi thin the ster ile field.

NOTE: The col or of the BioGli de Catheter s may change due to a ny coloratio n of the isotoni c saline solut ion used to hydrate the catheter prior to implantation.

CAUTION: USE O F SHARP INSTRUMENTS D URING HYDRATION OR H ANDLING CAN DAMAGE TH E SURFACE HYDROG EL OR CAN NICK, CRUSH OR C UT THE SILICONE ELA STOMER CATHETER, RE SULTING IN LEAKAGE AND NECESSITATING SHUNT REVISION.

10a

10b

Hydration Method

CAUTION: D O NOT USE ANY CONTAINER OTHER T HAN THE BIOGLIDE PACK AGING TRAY TO HYDR ATE OR SOAK BIOGLIDE PRO DUCTS. OTHER CON TAINERS MAY CONTAIN SOLUBLE RES IDUES, WHICH MAY BE TAKEN UP BY THE BIOGLIDE L AYER. THIS MAY RESULT IN ADVE RSE PATIENT REACTION S TO THE IMPLANT.

1. Peel ba ck the lid from t he catheter t ray.

2. Injec t sterile, f iltered, is otonic salin e into the cathe ter using a 30 cc sy ringe and fema le luer adapter.

3. Fill en tire lumen of c atheter with s aline. Contin ue injectin g fluid into t he catheter un til saline ex its the catheter, and the entire catheter becomes immersed in saline.

4. The ca theter may be ge ntly removed f rom the tray af ter a minimum hy dration peri od of two minu tes.

Ventircular Catheter

Tray

Female Luer Adapter

30 cc Syringe

Sterile Isotonic Fluid

PS Medic al®Snap Assembly Ventriculostomy Catheter

NOTE: The Vent ricular Cat heter with Sna p Assembly ba se is available s eparately or a s an integral un it with predetermined catheter lengths.

After t he ventricu lar catheter h as been place d, and attac hed to the rese rvoir bas e, the reser voir base may be s napped togeth er with the re servoir do me. A Snap Assem bly Tool is availab le separate ly to simplif y and exped ite the snap proced ure. Slip the “pro ngs” of the to ol under the re servoir ba se; then, snap th e dome onto the b ase (Fig12). Aft er the dome and b ase are snappe d together, the r eservoi r is placed in the 6m m burr hole or t wist drill h ole.

WARNING: VERIF Y COMPLETE SNAP ENGAG EMENT AND DO NOT DISA SSEMBLE THE RESERVOIR A ND BASE ONCE THEY AR E SNAPPED TOGETHER. T HE RESERVOIR AND BASE A RE DESIGNED FOR “ONE-TIME O NLY” SNAP ASSEMB LY. METICULOUS C ARE MUST BE TAKEN DURING ASSE MBLY TO PREVENT DAMAGE TO PL ASTIC COMPONENT S. DISASSEMBLY AND RE-AS SEMBLY AND/OR DAMAGE TO THE PL ASTIC COMPONENT S DURING ASSEMBLY CAN RE SULT IN UNWANTED DISCONNEC TION OR IN LEAKAGE O F THE ASSEMBLY.

Snap assembly tool

Ventricular catheter Incision

Dura

Burr hole

Skull surface

Snap shunt assembly

(underside view)

Snap connector

Integral ventriculostomy reservoir dome

PS Medical®Distal Catheters

Description

PS Medical® Distal C atheters a re available in a v ariety of co nguratio ns: small and st andard size s; open and clos ed tip; dierent slit congurations; pliant; reduced tip; barium impregnated; translucent and translucent with a radiopaque stripe. See packaging label for conguration details.

PS Medic al®Barium-Impregnated Dista l Catheter

Barium I mpregnated D istal Cathe ters are fab ricated fr om relatively  rm barium imp regnated sil icone elasto mer tubing for radiopacity.

PS Medic al®Distal Cathe ter with BioGli de

The Dist al Catheter w ith BioGli de has an interi or and exter ior hydroph ilic surfa ce modific ation for en hanced lubr icity and ease o f insertio n. The cathe ter is 90 cm in leng th, availabl e with a 1.3 mm inner d iameter, has an ope n end with wall slit s and is fabri cated of tra nslucent sili cone elastom er tubing wi th a barium-i mpregnate d radiopaqu e stripe. Relativ ely firm tu bing is incor porated in th e design to prov ide resist ance to cathe ter kinking a nd compress ion.

The cath eter has three n umeric leng th markers spa ced at 10 cm inter vals from the d istal tip. The Pe ritoneal Cathet er with BioGli de will contr ibute up to 1.5 cm H20 of addit ional resist ance to flow to t he shunt syst em at a consta nt flow rate of 2 0 mL/hr.

PS Medic al®Standard Distal Catheter

The Stand ard Distal C atheter has an o uter diamet er of 2.5 mm and an inn er diameter o f 1.3 mm (dimensions n ominal).

PS Medic al®Small Distal Catheter

The Small D istal Cathe ter has an outer d iameter of 2.1 mm and an inn er diameter of 1.2 m m (dimensions no minal).

PS Medic al®Distal Cathe ter with Wall Sli ts

The Dist al Catheter w ith Wall Slits ha s slit opening s placed 90° apa rt around th e circumfer ence of the cath eter. These openings are designed to provide protection from retrograde ow. They are not designed as pressure/ow contro l valves, but ad d slight resis tance to ow. Maxi mum resista nce to ow at a const ant ow rate of 20 ml /hour is 2.0 cm H2O for open -end cathe ters, and 3.5 cm H2O for clos ed-end cat heters. Th e slit openings a re coated wit h graphite during manufacture to minimize the possibility of slitted surface adhesion during storage.

PS Medic al® Translucent Distal Catheter

The Translucent Distal Catheter is fabricated from translucent, non-radiopaque silicone elastomer tubing.

PS Medic al® Translucent Distal Catheter with Radiopaque Stripe.

The Translu cent Distal C atheter with R adiopaque St ripe is fabri cated from t ranslucent si licone elast omer tubing with a st rip of radiop aque material e ncased wit hin the tubing w all.

PS Medic al® Pliant Distal Catheter

The Plian t Distal Cath eter is barium i mpregnated a nd is made of sof ter (lower dur ometer) tubin g.

PS Medic al® Reduced Tip D istal Catheter

The Redu ced Tip Dist al Catheter ha s a reduced- diameter ti p. The reduced -diamete r end of the cath eter has an oute r diameter of 1.5 mm and an inner diameter of 0.7 mm (dimensions nominal). The reduced-diameter tip is designed for use wher e the cathete r is to be placed i n a vessel with a l umen too small to a ccept larger d iameter cat heters.

PS Medic al® Open End Dis tal Catheter

The Open E nd Distal Cat heter is fabr icated fro m radiopaque s ilicone elas tomer tubing . As the distal t ip is open ended, t his catheter i s not indicate d for placemen t into the right a trium of the hea rt.

PS Medic al® Closed End Dist al Catheter

The Clos ed End Distal C atheter has a bu llet-shaped t ip lled with radiopaque tantalum-impregnated silicone elastomer (Fig13). The shape of th e tip is designe d for cardia c or peritonea l placement. Th e Closed -End Dista l Catheter has w all slit openin gs placed 90° ap art around the circumference of the catheter. These openings are designed to provide protection from retrograde ow. They are n ot designed as p ressure/ ow control val ves, but add sli ght resista nce to ow. Maximum r esistance to ow at a con stant ow rate o f 20 mL/hour is 3. 5 cm H20. The slit o penings are co ated with grap hite during manufacture to minimize the possibility of slitted surface adhesion during storage.

Indications

PS Medical®Dista l Catheters a re designed a s distal comp onents of CSF -Flow Control S hunts for use i n shunting cerebro spinal uid f rom the ventri cles of the bra in into the righ t atrium of the h eart or to the pe ritoneal cav ity. The redu ced-tip cat heter is recom mended for us e with patient s in whom the ca theter is to be pl aced in a vessel with a lum en too small to acce pt larger diame ter cathete rs.

The open t ip distal cat heters are not recommended for placement into the right atrium of the heart.

Instructions for Use

Distal Catheter Placement

A variet y of surgica l techniques m ay be used in plac ing the dista l catheter s into the right at rium, perit oneal cavit y, or other C SF diversion s ite. Site of place ment is at the dis cretion of th e surgeon.

The dist al catheter h as sucient le ngth for car diac or perito neal placemen t in most adult s. The open end d istal catheter is not recommended for placement into the right atrium of the heart.

If a subcu taneous tun neling device i s needed for p lacement of the d istal cath eter it is recom mended that th e PS Medical®reusa ble or dispos able Subcut aneous Cathe ter Passer be us ed.

The surg eon may trim the p roximal end fo r the select ed placement s ite at the time of su rgery. The ca theter shoul d be chec ked for patenc y at the time of su rgery, includ ing visual det ermination t hat all slit open ings will allow  ow of cerebrospinal uid.

CAUTION: LOW T EAR STRENGTH IS A CHAR ACTERISTIC OF MO ST UNREINFORCE D SILICONE ELASTO MER MATERIALS. CARE M UST BE TAKEN WITH THE HAND LING AND PLACEMENT OF TH E SILICONE ELASTO MER CATHETER TUBING TO AVOID C UTS, NICKS, OR TEAR S.

PS Medic al®Distal Cat heter with Bio Glide

Prior to ha ndling, conne ction and pl acement, the D istal Cathe ters with BioGli de must be full y hydrated in ste rile, filte red, isotoni c saline. Duri ng submersion, a portion of the hydrating solution is absorbed giving hydrophilic qualities to the surface. An ordinary silicone elastomer catheter has hydrophobic characteristics (Fig14a). The hy drophilic qua lities of BioGlide Catheters—lubricity and smoothness—are shown in Figure14b. Full hydration is accomplished in a minimum of two minutes. BioGlide Cathet ers are packa ged in trays wi th a built-in wel l to accommodate t he hydrating solution and a channel for catheter submersion (Fig15).

Tray

Sterile Isotonic Fluid

Contoured

Polypropylene

shield

Pressure Dots

base

Radiopaque Pressure Dots

Outlet Ports

Radiopaque Pressure Dots

Silicone Membrane Valve

Radiopaque pressure dots

Reservoir

Polypropylene base

Radiopaque marker

Integral inlet connector

Radiopaque ﬂow directon arrow

Silicone dome

Reservoir

Occluder

Standard

Silicone Dome

Radiopaque

Marker

Polypropylene Base

Outlet Ports

Burr Hole

Polypropylene plastic needle

Silicone

dome

Suture

hole

Silicone

membrane

valve

Ultra Small

Reservoir

Silicone Dome

Radiopaque

Marker

Polypropylene

Base

Button

Reservoir

Outlet port

CAUTION: C ATHETER MUST BE FULLY HYDRATED PR IOR TO REMOVAL FROM TRAY, INSERTI ON OF STYLET, AND ALL OTHER HANDL ING OPERATIONS. HANDLI NG WITHOUT FULL HYDR ATION COULD DAMAGE THE C ATHETER’S HYDROG EL SURFACE.

CAUTION: D O NOT INSERT STYL ET INTO CATHETER LUMEN PRI OR TO FULL HYDRATION.

B-D

30 cc SyringeFemale Luer Adapter

Peritonieal Catheter

Radiopaque ﬂo direction arrow

Silicone membrane valve

Radiopaque Flow Direction Arrow

Reservoir

Radiopaque Flow Direction Arrow

Occluder

Silicone Membrane Valve

Plastic base

14a

14b

Occluder

Connector

Integral outlet connector

200

180

160

145

140

120

100

5 20 30 40

Dot Code Low-Low Pressure — Low Pressure • Medium Pressure •• High Pressure •••

NOTE: The col or of the BioGl ide Cathete rs may change du e to any colorat ion of the isot onic saline s olution use d to

hydrate the catheter prior to implantation.

CAUTION: USE O F SHARP INSTRUMENT S DURING HYDRATION O R HANDLING CAN DAM AGE THE SURFACE HYDROG EL OR CAN NICK, CRUSH O R CUT THE SILICONE EL ASTOMER CATHETER , RESULTING IN LEAKAG E AND NECESSITATING SHUNT REVISION.

High Pressure

Medium Pressure

Low Pressure

Low-Low Pressure

NOTE: Levels depicted are median values. All valves perform within +/- 25 mm

170

H2O of these median values when tested at time of manufacture. Low-Low Pressures are within +/- 10 mm H

O at 5 mL/hr

and +/- 20 mm H at time of manufacture.

105

Every PS Medical valve is tested for its performance characteristics using a water-lled system at the time of manufacture to assure consistent high

quality. All valves must conform to labeling specications in these tests.

Subsequent testing of the valve may give dierent results depending on test conditions and condition of the valve.

O at 50 mL/hr

Hydration Method

1. Peel ba ck the lid fro m the catheter t ray.

2. Injec t sterile, f iltered, is otonic salin e into the cathe ter using a 30 cc sy ringe and fema le luer adapter.

3. Fill en tire lumen of c atheter with s aline. Contin ue injectin g fluid into t he catheter un til saline ex its the catheter, and the entire catheter becomes immersed in saline.

4. The ca theter may be ge ntly removed f rom the tray af ter a minimum hy dration peri od of two minu tes.

Catheter Pa tency Check

1. Inser t a 17-gauge blunt ne edle into the o pen, proximal e nd of the cathe ter and ush wit h gentle syri nge pressure using sterile physiological saline.

2. Obse rve the slit op enings near th e distal end. A ll openings sho uld allow uid o w and appear to op en for their entire length.

3. Gent ly rolling the sl it opening are a of the cathet er between t he thumb and for enger will f ree the slits i f they do not a ppear to open co mpletely.

4. Smoot h the cathete r wall with the t humb and fore nger so the slit o penings are in c losed posi tion after completion of the patency test.

PS Medical®CSF-Flow Control Valves

Description

PS Medical® CSF-ow c ontrol valve s, Contoured, Standard, Bu rr Hole, Ultra S mall, and Butt on are diagram med in gures 16 through 20 . These v alves are fabr icated fro m silicone elas tomer and poly propylene. T he Contoured Va lves are availab le in two mo dels, Regular a nd Small, to accomm odate diere nt patient gr oups. The Burr H ole Valves are ava ilable in two sizes: 12 mm and 16 mm . The Contoure d, Standard, and Burr Hole Valves come in low, medium, and high-pressure ranges. The Ultr a Small and But ton Valves have an ult ra-low pro le for use in pre mature infan ts and come in low -low, low, and medium pressure ranges.

All valve s are marked wit h a tantalum- impregnate d radiopaqu e arrow to indic ate proximal to d istal ow dir ection (with the exception of the Burr Hole Valves), and a radiopaque dot code that allows x-ray identication of the valve pre ssure. Radio paque marker s at the base of ea ch connecto r allow the physi cian x-ray visu alization of t he relativ e positions of c atheters a nd valve in vivo when radiopaque catheters are used.

All valve s (with the excep tion of the But ton Valves) inclu de The Conto ured Valves inc lude proximal a nd distal occ luders for t wo-way ush ing. The Ultra Sm all Valves inclu de one ushing occluder.

The valve s are available i n a variety of s izes and press ure ranges. P ressure/o w character istics and d ot codes of all th e valves ar e shown in gure s 21 and 22.

Indications

The CSF- ow control va lves, Contoure d, ow contr ol shunts des igned to provi de controlle d CSF ow from t he ventricle s of the brain int o the right atr ium

of the hear t or the

peritoneum.

Standard,

Instructions for Use

Surgical Technique

A variet y of surgica l techniques m ay be used in impl anting CSF- ow control val ves. The follo wing surgica l techni que is intended t o be used only as a g uideline; ac tual implant ation techni que and site of pla cement must b e determined by the physician, based on individual patient needs. Immediately prior to surgery, the patient should be posit ioned with he ad turned to th e side opposit e that of the plann ed shunt place ment site. The ne ck should be slightl y hyperext ended, and a smal l rolled cushi on should be pla ced under the sh oulder of the op erative side. To ensure th at the tunneli ng device can be p assed in a str aight line, the re should be no f olds or creas es in the neck.

Connec t valve to cathe ters by inser ting valve in tegral conne ctors into c atheters . For Button Val ves, a straigh t connec tor should be u sed. Connec tors should b e completely c overed by cath eter tubing. S ecure cathe ters to connectors with encircling ligature. Contoured, Ultra Small, at sur face adjacent t o the pericra nium. The Burr H ole Valve is desig ned to t into a fo rmal burr hole . The upper surf aces of the distal ly (in the direc tion of CSF ow). Su ture holes ar e provided on th e Burr Hole Valve  anges to accomm odate valve-to-tissue anchoring. The Contoured, passing a suture through the fabric-reinforced anges.

CAUTION: USE O F SHARP INSTRUMENTS W HILE HANDLING THESE DEV ICES CAN NICK OR CUT T HE SILICONE ELASTO MER, RESULTING IN LEAK AGE AND NECESSITATING SHUNT RE VISION. CARE MUST BE TAKE N WHEN CLOSING INCIS IONS TO ENSURE THAT THE VALVES ARE NO T CUT OR NICKED BY SUTURI NG NEEDLES.

CAUTION: SH UNT OBSTRUCTION M AY OCCUR IN ANY COMPONEN T OF A SHUNT SYSTEM AND SH OULD BE DIAGNOSED BY C LINICAL FINDINGS. VALVE FLUSHIN G CHARACTERIST ICS MAY NOT BE ADEQUATE TO DIAGNOSE OCC LUSION OF THE CATHETER S. SEE WARNINGS AND PRECAU TIONS SECTION.

Standard,

Contour ed, Ultra Small, a nd Button Valv es are marked wi th a radiopaq ue arrow point ed

Standard

Injection into the Valve CSF-ow con trol valves (other th an the Button Val ve) are designed to allow injection throu gh the dome via 25-gau ge or smaller no ncoring needl es (Fig23).

CAUTION: TH E BUTTON VALVES ARE NOT DESI GNED TO ALLOW INJEC TION WITH A NEEDLE. A SE PARATE RESERVOIR O R ANTECHAMBER IS REQUIR ED FOR CSF ACCESS.

CAUTION: LOW T EAR STRENGTH IS A CHARACTERISTIC OF UNREINFORCED SILICONE ELASTO MER MATERIALS. CARE M UST BE TAKEN ON INSERTION A ND REMOVAL OF THE NEEDLE.

The need le should be ins erted at an ang le no greater than 45° from th e scalp or valve b ase. If the valve w ill be punc tured sever al times, it is re commended t hat the needle be inserted at various locations to avoid multiple punctures at a single point. The catheter tubing and occlud ers should not b e used as injection site s.

CAUTION: TH E PRESSURE CONTROL MEM BRANE OF THESE DEV ICES IS NOT DESIGNED TO A LLOW NEEDLE PENETRATIO N: SUCH PUNCTURE MAY AFFEC T THE PRESSURE/FLO W CHARACTERISTI CS OF THE VALVE AND COMPROMISE THE SHUNT SYSTEM.

CAUTION: PART ICULATE MATTER IN SOLUT IONS USED TO TEST VALVES MAY RES ULT IN IMPROPER PRODUCT PERFORMANCE.

CAUTION: TAKE CARE TO MAINTAIN STERILITY AND TO AVOID PARTICULATE CONTAMINATION.

CSF-Flow Control Valves: Patenc y Check

Standa rd (Fig 24), and Contoured (Fig 25) Valves Patency Check

a. Plac e the inlet conn ector of the va lve into steri le isotonic sa line. b. Pump the v alve by depres sing and relea sing the centr al reservoi r section o f the valve to ll wi th uid and

displace all air.

c. Depres s and release t he valve centra l reservoi r repeatedly u ntil uid ows o ut of the outle t connector. If

uid ows f rom the outl et connect or each time the c entral rese rvoir is depr essed, the val ve is patent.

CAUTION: E XCESSIVE FLUSHING PRE SSURE MAY CAUSE TEMPOR ARY DEFORMATION OF T HE CSF-FLOW CONTROL VALVE MEMBR ANE AND RESULT IN ABNORM ALLY LOW PRESSURE/FLOW TES T RESULTS.

Ultra Sma ll Valve Patency Chec k (Fig 26)

a. Attach 16-gauge blunt needle adapter, tubing, and syringe to the valve inlet. b. Prel l valve and tubin g. c. Occlude inlet tubing. d. Depre ss dome. If uid  ows out of the out let connec tor, the valve is pat ent.

Fluid Line

Sterile Istotonic Fluid

Outlet

Pump Dome

Inlet

Burr Hole Val ve Patency Check (Fig 27)

a. Plac e the inlet conn ector of the va lve into steri le isotonic sa line. b. Depress the valve dome. c. Place a ng er over the openi ng at the end of the o utlet conne ctor. d. Releas e the depress ed dome. If uid e nters the res ervoir, the inl et connect or and ow contro l membrane

valve are patent.*

e. Remove nger from the outlet connector opening. f. D epress dome. I f uid ows out of t he outlet conn ector, the valv e is patent. * * NOTE: It may be ne cessary t o depress the va lve dome more th an once to initia te ow, especial ly if the

an injec table

dome and a p olypropyle ne needle guar d.

Burr Hole, Ultra Small, and Button, are the components of CSF-

Standard,

and But ton Valves are pla ced with the

and Ultr a Small Valves may be s utured to adja cent tissue by

25-gauge needle or smaller

Outlet

Pump Dome

Inlet

Fluid Line

Sterile Isotonic Fluid

ventric ular cathet er has been att ached prio r to patency te sting.

Button Va lve Patency Check (Fig 28)

a. Attach a 16-g auge blunt nee dle and syrin ge to the valve inl et. b. Flush the valve wi th sterile i sotonic sali ne. c. If uid ow s out of the dis tal connec tor, the valve is pate nt.

Sterile Isotonic Fluid

10 cc Syringe (lled with sterile isotonic saline)

Compress valve dome

Occlude distal catheter connector

Fluid Line

16-gauge Blunt Needle Adapter

Release valve dome

10 cc Syringe (lled with sterile isotonic saline)

16-gauge Blunt Needle Adapter

Depress dome

Outlet

Inlet

Pump Dome

Occlude Tubing

Outlet

Preimpl antation Test

Each CSF -ow control v alve is tested t o ensure confo rmance with i ts labeled pe rformanc e character istics. Althou gh vericati on of a valve’s dyna mic perfor mance charac teristic s using a stat ic test that ca n be perfor med in the ope rating room is n ot possible, t he surgeon may w ish to verify t hat the valve con forms to Med tronic Neurosurgery’s specications prior to implantation. The following preimplantation test may be performed in the operating room:

CAUTION: TAKE CARE TO MAINTAIN STERILITY AND TO AVOID PARTICULATE CONTAMINATION.

Test Method I. Equipment required for test

1. S terile uid re servoir or s terile water b ath

2. One sterile 30 cm water manometer, graduated in centimeters

3. O ne three-w ay stopcock (to b e used with man ometer)

4. O ne sterile s yringe, 30 cc

5. O ne sterile 5 µ s yringe lter

6. O ne sterile ma le Luer connec tor

7. Sterile silicone tubing

II. Equipm ent setup

Remove ca p from manome ter. Set up manome ter, stopcock , and water bath s o that the zero le vel on the manome ter and the uid l evel in the wate r bath are the sa me height (Fig29). (Fi x manometer t o an I.V. stand.)

2. F ill syringe w ith sterile w ater using 5 µ sy ringe lter. (Wh en relling sy ringe, alway s use 5 µ syringe  lter.) After lling syringe, detach syringe lter.

Manometer cap (detached)

Syringe lter (detached)

Syringe

3. Connect syringe, manometer, and silicone tubing as shown in Figure 29.

4. To purg e all air from t he assemble d sterile tes t apparatus t urn stopco ck as shown in Fig ure 30a.

5. Subme rge silicone t ubing in the ste rile water bat h and ush with s terile water f rom syring e.

III. Equipment calibration

1. Turn sto pcock as shown i n Figure 30b and ll man ometer to at leas t 5 cm H2O.

2. With silicone tubing submerged in the water bat h, turn stopc ock to isolate syringe from the manometer (Fig 30c).

3. Allow w ater column in th e manometer to fall.

4. Water co lumn should st op at zero level of the manometer, as shown in gure29. If n ot, raise or lowe r manometer accordingly.

5. Manom eter is now cali brated to the zero leve l of the water bat h. Fix or mount the manometer to maintain refere nce position w ith water bat h.

Manometer

Stopcock

IV. Test procedure

NOTE: Durin g testing, th e valve must be

submer ged in the ster ile water bath. F or correct result s, the zero level o f the manomete r must be prope rly aligned w ith the uid leve l of the water bath.

1. C onnect the s terile valve to b e tested to the asse mbled steri le test appar atus.

2. Tur n stopcock as s hown in gure30 b and ll man ometer to at leas t 30 cm H2O.

3. Tur n stopcock to i solate manome ter from ow p ath as shown in g ure30a.

4. P urge all air fr om the valve and th e assemb led test appa ratus by gentl y ushing w ith sterile w ater from syringe.

5. G ently esta blish ow throu gh the valve with ste rile water fr om the syrin ge.

6. S ubmerge ste rile valve in the s terile water bat h. The outlet c onnector of t he valve must b e under water to ob tain correc t test resul ts.

7. W hile gently ma intaining ow t hrough the va lve, turn stop cock to isolate s yringe fr om ow path as shown in g ure 30c. Aft er stopcock is p laced in prop er position, t he water column i n the manomete r should s tart to fall. T he syringe i s now isolated f rom the valve an d continuing o w with the syr inge is no longer ne cessary. If w ater column doe s not fall, repe at steps 2 thro ugh 7.

NOTE: Allow w ater level in the m anometer to fa ll for 2 to 2 ½ minute s. Read the resu ltant press ure from the manometer.

Silicone tubing

Correct manometer alignment

30a

From syringe

30b

30c

30 cm

1/4

From syringe

O

-3

F F

O

-3

To manometer

-3

From manometer

C water bath

Connect product her

To valve

Test Result s – Preimplanta tion Test

The resu ltant pressu re reading may b e compared wi th the followi ng characte ristics:

Valve Pressure Range Acceptable Pressure Range

Low-Low ................................................................................ 0 –20 mm H2O

Low ........................................................................................ 1–50 mm H2O

Medium ............................................................................. 50–110 mm H2O

High ..................................................................................110–170 mm H2O

PS Medical®CSF-Ventriculostomy Reservoirs

Description

CSF-ventriculostomy reservoirs are designed to provide percutaneous access to the ventricular cerebrospinal uid (CSF). Any PS Medical®CSF-ventriculostomy reservoir can be used independently as a reservoir or as a component of a PS Medical®CSF-ow control shunt.

CSF-ven triculost omy reserv oirs have a 6 mm-d iameter bur r hole, polypr opylene base, a nd a radiopaq ue, barium impregnated, silicone elastomer dome.

The base c ontribute s to struct ural integri ty and preven ts penetra tion of the res ervoir base b y the needle du ring

percutaneous injection. The bas e is made with an in tegral cath eter connec tor designe d to facilita te implantati on and decrease the possibility of catheter disconnection. One encircling ligature is required to secure the catheter to the inle t connector. Th e radiopaque r eservoir d ome allows the p hysician to vis ualize by x-ray th e relative pos itions of the res ervoir dome a nd the radiop aque cathet er if disconne ction is susp ected. All r eservoir s are speciall y design ed to t into a 6 mm (¼”) di ameter burr ho le or twist dr ill hole. Any PS Medical®CSF -ow control v alve may be direc tly connec ted to the res ervoirs.

Ventriculostomy Reservoir

The Pull-Over Ventriculostomy Reservoir (Fig31) is available i n two mod els: 6 mm Burr Hol e Base, Shallow, and 6 m m Burr Hole Bas e, Regular Depth.

The flu id volume ca pacity of

the res ervoirs i s:

Burr Hol e, 6 mm Regular

Depth: ............ .15 m L

Burr Hol e, 6 mm Shallow

Depth: ............ .10 m L

Unitized Ventriculostomy Reservoir

The Unitized Ventriculostomy Reser voir is one inte gral assembl y. It has a 6 mm base, integral to the reservoir dome. The uid volume c apacity of t he base is .15 mL (Fig32).

Radiopaque Silicone Dome

Plastic Base

Plastic Straight Connector

Plastic Tubing Plug

Snap Assembly Ventriculo stomy Reservoir

The Snap Assembly Ventriculostomy Reservoir facili tates connec tion of the pr oximal and dis tal compone nts of a CSF-Shun t and should be us ed with a snap asse mbly reser voir base. The  uid volume capaci ty of the bas e is .15 mL (Fig33).

Indications

CSF-ven triculost omy reserv oirs, when con nected to ventric ular cathet ers, provide a ccess to the late ral cerebral ventricles. They may be used independently as reser voirs, or as c omponents o f PS Medical®CSFow control shunts.

Instructions for Use

Ventricular Catheter Placement

A variet y of surgica l techniques m ay be used in plac ing the ventri cular cathe ter. Site of placeme nt is at the discre tion of the sur geon. The vent ricular cath eter may be place d into the later al ventricle u sing a stainle ss steel styl et as a guide. Aft er placement an d trimming (if n ecessar y) the catheter i s attached t o the assemble d reservoi r at the bas e inlet connec tor by an encir cling ligatur e. The assembl ed CSF-ventr iculostom y reservoi r is placed in the 6 mm burr ho le or twist dr ill hole.

Alterna tely, the cathe ter length may b e gauged bef ore inser tion and trim med. After t rimming, th e catheter may b e xed to the r eservoi r base by an enci rcling ligat ure (non-uni tized versi ons only). The cat heter and bas e may then be placed as a n assembly us ing a stainle ss steel st ylet. Aft er catheter p lacement, th e silicone ela stomer cap is  tted over the rese rvoir base , and the assem bled CSF-ven triculos tomy reser voir is placed i n the burr hol e or twist dr ill hole.

CAUTION: D O NOT PUNCTURE THE SILI CONE CAP WITH THE ST YLET DURING CATHETE R PLACEMENT. THIS MAY RESULT IN LEAK AGE THROUGH THE CAP AF TER RESERVOIR IMPL ANTATION.

Reservoir Placement

The placement of the reservoir can be accomplished through a variety of surgical techniques. Placement method is at the dis cretion of t he surgeon. Th e location se lected for t he reservo ir should prov ide adequate ac cess for injection throu gh the reser voir dome, and if d esired, allow f or the possib le addition o f a CSF-ow cont rol shunt. The dome is designed to allow injection via a 25-gauge or smaller noncoring needle. Complete penetration of the reser voir by the nee dle will be preve nted by the rm p olypropyle ne base. The res ervoirs a re designed to  t snugly into a 6 mm bur r hole or twis t drill hole.

Use of Reser voir Only

To use the res ervoir wit hout connec tion to a CSF shun t, push the plas tic tubing pl ug into the rese rvoir dome o utlet and secu re with one enc ircling ligat ure (Fig34).

Use of Reser voir in a CSF-Shunt

To connec t the reservo ir for use as a shu nt component , push the stra ight connec tor into the res ervoir dom e outlet arm and se cure with one e ncircling li gature. The re servoir is no w ready to be conne cted to a PS Medical®CSF-shunt by suturing the connector to the inlet tubing of the shunt. A PS Medical®CSF-ow contro l valve or shunt w ith an integr al inlet conne ctor may be dire ctly conne cted to the re servoir, wit hout using the s eparate conn ector (Fig35).

25 Gauge or Smaller Needle

Tubing

Plug

Injec tion into the Rese rvoirThe CSF-ventricu lostomy reser voir is design ed to allow injection through th e dome by use of a 25-gauge o r smaller nonco ring needle.

CAUTION: LOW T EAR STRENGTH IS A CHAR ACTERISTIC OF MO ST UNREINFORCED SILICO NE ELASTOMER MATERIALS. C ARE MUST BE TAKEN ON INSERTI ON AND REMOVAL OF THE NEEDLE .

The reservoir is designed to allow multiple punctures. Inserting the needle at various locations to avoid repeated punct ures at a single p oint on the cap i s recommende d.

Produc t perfor mance tests i ndicate that t he CSF-ventr iculostomy r eservoir w ill tolerate up t o 100 punctur es with a 25- gauge or small er noncoring n eedle. Actu al product p erforman ce may vary dep ending upon in jection techni que, needle t ype and size.

Snap Assembly Ventriculo stomy Reservoir

NOTE: The Sna p Assembly Ven triculost omy Reservo ir Dome must be u sed with a snap a ssembly bas e. NOTE: The Vent ricular Cat heter with Sna p Assembly ba se is available s eparately or a s an integral un it with

predetermined catheter lengths. After t he ventricu lar catheter h as been place d, and attac hed to the rese rvoir bas e, the reser voir base may be s napped

togeth er with the re servoir do me. A Snap Assem bly Tool is availab le separate ly to simplif y and exped ite the snap proced ure. Slip the “pro ngs” of the to ol under the re servoir ba se; then, snap th e dome onto the b ase (See Figur e 12). After t he dome and bas e are snapped to gether, the re servoir is p laced in the 6 mm bu rr hole or tw ist drill hol e.

WARNING: VERIF Y COMPLETE SNAP ENG AGEMENT AND DO NOT DIS ASSEMBLE THE RESER VOIR AND BASE ONCE THEY AR E SNAPPED TOGETHER . THE RESERVOIR AND BA SE ARE DESIGNED FOR “O NE-TIME ONLY” SNAP ASSEMB LY. METICULOUS C ARE MUST BE TAKEN DURING AS SEMBLY TO PREVENT DAMAG E TO PLASTIC COMPONENT S. DISASSEMBLY AND RE-A SSEMBLY AND/OR DAMAGE TO THE PL ASTIC COMPONE NTS DURING ASSEMBLY CAN RE SULT IN UNWANTED DISCONNEC TION OR IN LEAKAG E OF THE ASSEMBLY.

Snap Asse mbly Ventriculos tomy Reservoi r Hydration Instr uctions (Fig 36)

Prior to ha ndling, con nection, a nd placemen t of the valve or s hunt, it must b e fully hydr ated with st erile, lter ed, isotoni c saline. Fu ll hydratio n is accomplis hed in a minimu m of two minut es. Each PS Medical®va lve and shunt w ith BioGlid e is packag ed in a tray, with in a well, which a ccommodate s the hydrati ng solutio n.

NOTE: If pre sent, the Del ta® siphon control mechanism does not have the hydrophilic surface modication. CAUTION: D O NOT HANDLE BIOGLIDE CO MPONENTS PRIOR TO FULL H YDRATION. SUCH HAN DLING MAY

CAUSE DAMAG E TO THE SURFACE HYDROGE L. CAUTION: D O NOT HANDLE BIOGLIDE C OMPONENTS WITH SHA RP INSTRUMENTS; PROD UCT DAMAGE MAY RESU LT. NOTE: The col or of the BioGli de-enhanc ed product m ay change due to any c oloration o f the isotonic s aline

soluti on used to hydra te the valve prio r to implantat ion. NOTE: The Bi oGlide hydro gel layer may be subj ect to wear ove r time, which cou ld expose th e silicone elas tomer

beneath i t. The produc t surface t hus expose d would not have th e enhanced BioG lide proper ties, i.e., a hydr ophilic surf ace and lubric ity.

Hydration Method

CAUTION: D O NOT USE ANY CONTAINER OTHER TH AN THE BIOGLIDE PACKAGI NG TRAY TO HYDRATE OR SOA K BIOGLIDE PRO DUCTS. OTHER CONTAINE RS MAY CONTAIN SOLUBLE RESID UES, WHICH MAY BE TAKEN UP BY THE BIOGLIDE L AYER. THIS MAY RESULT IN ADVER SE PATIENT REACTIONS TO T HE IMPLANT.

1. Peel ba ck the Tyvek lid f rom the valve hyd ration tray.

2. Atta ch a 60 cc syrin ge to the blunt ne edle include d in the tray and l l the syring e with saline.

3. Inser t blunt nee dle and syrin ge into prell ad apter.

4. Atta ch syringe a nd adapter ass embly to the Snap R eservoir B ase.

5. Fil l entire shunt w ith uid. Con tinue injec ting uid unt il saline ex its the dist al cathete r, and the entire sh unt is immersed in saline.

6. The sy ringe may have to b e relled to ll t he entire tray we ll.

7. Ensur e that the shunt i s completely su bmerged for a f ull two minu tes.

Shunt Pate ncy Test, Snap Assem bly Ventriculost omy Reservoir

A prell a dapter and a blun t needle are pro vided with ea ch Snap Shunt As sembly Ventri culostomy Re servoir Do me to facilitate preimplantation processing.

Shunt Pate ncy Check (Fig 40)

1. Attach t he transluce nt prell adap ter to the inlet o f the reser voir dome.

2. Using t he 16-gauge blu nt needle ada pter, ll a syring e with steril e, ltered, iso tonic saline.

3. Inser t the blunt ne edle adapter i nto the port o f the prell adap ter, and using gent le syringe p ressure, ush shun t assembly wi th the saline.

4. If the s aline ows out o f the distal c atheter end, th e shunt assemb ly is patent.

NOTE: Pressure/ow test instructions are available upon request from the Medtronic Neurosurgery

Customer Service department.

3534

Straight connector

Tubing

PS Medical®CSF-Shunt Assemblies and Shunt Assembly Kits

10 cc Syringe (lled with sterile isotonic saline)

Flow Rate (mL/hr)

Pressure (mm H

performance characteristics using a water-lled

Flow hole

Right angle clip

Elastic silicone tube

Stainless steel stylet

push into tab groove

VentricleSkull

Description

CSF-Shunt A ssemblie s and Shunt Asse mbly Kits inc lude a CSF-Fl ow Control Valve an d an integral di stal cathe ter. Shunt As sembly Kits a lso include a s eparate ventr icular cath eter. CSF-Flow Co ntrol Valves ar e available in low -low, low, or medium pressure valves (Ultra Small and Button); or low, medium, or high-pressure valves (Contoured, Standard,

and Burr Hole). The radiopaque dot code on the valve indicates valve pressure. The pressure/ow

charac teristic s of the valve are s hown in gures 21 and 22. A variet y of PS Medical® components have been combined to create unique shunt assembly systems. Refer to the

produc t label and th e CSF-Flow Con trol Valve, Ventr icular Cath eter, and Dista l Catheter se ctions fo r descript ions of these shunt components.

The valve s are constru cted with an i ntegral inle t connecto r, which allows conn ection to a ve ntricular c atheter. Metal-free implantable components ensure distortion-free CT or MR imaging. Radiopaque markings indicate valve

pressure, ow direction and valve-to-catheter approximation. The catheters are kink and compression resistant. NOTE: The pr essure/o w character istics dep icted in gu re 22 pertain to the individual valve. Although minimal,

the integ ral periton eal cathete r will increas e resistanc e to ow as compare d to an individu al CSF-Flow Co ntrol Valve. The ma ximum addit ional resist ance to ow at a cons tant ow rate o f 20 mL/hr is 2 cm of H2O for open -end distal c atheters a nd 3.5 cm H2O for clos ed-end dis tal cathete rs.

Indications

CSF-Shunt Assemblies and Shunt Assembly Kits are designed as components of CSF-Flow Control Shunts for

use in shun ting CSF fro m the ventricl es of the brain in to the right at rium of the hear t or to the peri toneal cavit y.

Instructions for Use

Surgical Technique

A variet y of surgic al technique s may be used in pl acing the CSF -Shunt Assemb lies. Shunt s ize and pressu re range are at the dis cretion of th e surgeon. Th e valve is place d with the at su rface adja cent to the per icranium. Th e valve may be secu red to adjacen t tissue by sutu ring throug h its fabri c-reinforced a nge (Contoure d, Burr Hole Valves).

Immediately prior to surgery, the patient should be positioned with the head turned to the side opposite that of the shun t placement. T he neck should b e slightly hyp erextend ed and a small roll ed cushion pla ced under the shoulde r of the operat ive side. There s hould be no fold s or creases in t he neck so that t he tunneling d evice can easily be p assed in a str aight line.

PS Medical®Shunt Assembly with BioGlide (Fig 36)

Prior to ha ndling, con nection, a nd placemen t of the valve or s hunt, it must b e fully hydr ated with st erile, lter ed, isotoni c saline. Fu ll hydratio n is accomplis hed in a minimu m of two minut es. Each PS Medical®valve and shunt with BioGlide® is packag ed in a tray, with in a well, which a ccommodate s the hydrati ng solutio n.

NOTE: If present, the Delta® siphon control mechanism does not have the hydrophilic surface modication. If presen t, the Delta sip hon control m echanism doe s not have the hydro philic sur face

modication.

CAUTION: D O NOT HANDLE BIOGLIDE CO MPONENTS PRIOR TO FULL H YDRATION. SUCH HAN DLING MAY CAUSE DAMAG E TO THE SURFACE HYDROGE L.

CAUTION: D O NOT HANDLE BIOGLIDE CO MPONENTS WITH SHARP I NSTRUMENTS; PRODUC T DAMAGE MAY RES ULT.

NOTE: The col or of the BioGli de-enhanc ed product m ay change due to any c oloration o f the isotonic s aline

soluti on used to hydra te the valve prio r to implantat ion. NOTE: The Bio Glide hydrog el layer may be subje ct to wear over t ime, which coul d expose the si licone elast omer

beneath i t. The produc t surface t hus expose d would not have th e enhanced BioG lide proper ties, i.e., a hydr ophilic surf ace and lubric ity.

CAUTION: D O NOT USE ANY CONTAINER OTHER TH AN THE BIOGLIDE PACKAGI NG TRAY TO HYDRATE OR SOA K BIOGLIDE PRO DUCTS. OTHER CONTAINE RS MAY CONTAIN SOLUBLE RESID UES, WHICH MAY BE TAKEN UP BY

THE BIOGLIDE L AYER. THIS MAY RESULT IN ADVER SE PATIENT REACTIONS TO T HE IMPLANT.

Hydration Method

1. Peel ba ck the Tyvek lid f rom the valve hyd ration tray.

2. Atta ch a 60 cc syrin ge to the luer-lo ck connecto r and ll shunt.

3. Fill valve and entire lumen of integral catheter with sterile, ltered, isotonic saline. Continue injecting uid into t he catheter u ntil saline ex its the cath eter, and the enti re shunt becom es immerse d in saline.

4. Ensur e that the shunt a ssembly wit h BioGlide is co mpletely sub merged for a fu ll two minute s.

NOTE: Prior t o implantati on, remove and dis card luer-lo ck connect or and the clear t ubing atta ched to it.

Ventricular Catheter Placement

A variet y of surgica l techniques m ay be used in plac ing the cathe ters into the la teral ventri cle. Site of place ment is at the dis cretion of t he surgeon. Th e surgeon may tr im the distal e nd of the ventri cular cathe ter for the sel ected placeme nt site at the time o f surgery.

The righ t angle clip may be u sed to bend the ve ntricular c atheter to an ap proximate 90˚ a ngle where it e xits the twis t drill or burr ho le (Fig6, see cat heter sect ion). (The clip mu st be removed wh en the cathet er is used with the Burr H ole Valve). The clip may b e used as a marker f or planned de pth of cathete r insertio n by sliding it th e approp riate distan ce from the pr oximal tip of the c atheter pri or to insert ion (Fig7); this ca n be done with th e styl et in the cathe ter. After the ca theter is prop erly positi oned in the vent ricle, the ex tracrani al portion o f the cathet er is pressed i nto the split tu bular segmen t of the clip to fo rm the right ang le bend (Fig8 and F ig9). Avoid stretc hing the cath eter when it is pr essed into th e clip. If the cat heter is to be pla ced in the ventr icle through a tubular i ntroducer, the c lip must be rem oved prior to in sertion of t he catheter th rough the int roducer.

It is reco mmended that t he right angle c lip be secure d to adjacent tis sue by passing s utures thro ugh the two suture h oles on the side s of the clip (Fig6). If t he right angle c lip is not used, i t is recommen ded that the sur geon trim the r im of the twis t drill or burr h ole to provide a b eveled notch w here the cath eter emerges a nd curves to l ie adjacen t to the skull.

Ventricular Catheter Attachment

NOTE: A vent ricular cath eter is includ ed with the CSF -Shunt Assemb ly Kits. To connec t a shunt assemb ly to a ventric ular cathet er, insert the i nlet connec tor into the ven tricular c atheter tub ing.

The connector should be completely covered by tubing. Secure tubing to the connector with an encircling ligature. Care sho uld be taken to en sure that the li gature resu lts in a secur e connecti on, but does n ot cut the tubi ng.

A subgale al pocket mus t be formed wi th appropri ate depth to accep t the extra cranial por tion of the ven tricular catheter and the valve component of the shunt assembly. It is recommended that the implantation of the ventric ular cathet er be the last st ep in the shunti ng procedure t o minimize loss o f CSF during su rgery.

Injec tion into the Valve The d ome of the Valves is de signed to allow injec tion via a 25-gauge or s maller nonco ring needle (Fig23). The rm polyp ropylene base is d esigned to help p revent comple te penetratio n of the valve.

CAUTION: TH E BUTTON VALVE IS NOT DESIGN ED TO ALLOW INJECTION WITH A NEEDLE.

Distal Catheter Placement

Site of placement is at the discretion of the surgeon. The integ ral distal c atheter of a shu nt assembly may h ave an open or clo sed tip. The clo sed-end ca theter has a

bullet-s haped tip. The s hape of the tip is d esigned for b oth cardiac an d peritoneal p lacement. Th e distal cath eter with ope n tip is not recom mended for c ardiac placem ent.

A variet y of surgica l techniques m ay be used in plac ing the dista l catheter in to the periton eal cavity, or ot her CSF divers ion site. The sit e of placement is a t the discret ion of the surge on. The cathe ter should be ch ecked for pat ency at the tim e of surgery. Se e the Catheter P atency Chec k in the Cathet ers secti on of this inser t for direc tions.

If a subcu taneous tun neling device i s needed for p lacement of the d istal cath eter it is recom mended that th e PS Medical®reusa ble or dispos able Subcut aneous Cathe ter Passer be us ed.

The Disp osable Cath eter Passer i s designed to b e directed d istally th rough the sub cutaneou s space with th e handle an d obturator i n place. The tub ular passer sh aft is malle able and may be han d formed by th e surgeon. Af ter placeme nt of the passe r, the obturato r is unlocked f rom the handl e and the handle i s removed fro m the passer sh aft. The dist al end of the per itoneal ca theter is then p laced on the ob turator end  tting. Obt urator and c atheter are th en drawn th rough the pas ser shaft by p ulling the dis tal obtura tor tip. The obt urator is the n removed fro m the cathet er tubing. The passer shaft can now be withdrawn caudally through the abdominal incision.

CAUTION: LOW T EAR STRENGTH IS A CHAR ACTERISTIC OF MO ST UNREINFORCED SILICO NE ELASTOMER MATERIALS. C ARE MUST BE TAKEN IN HANDLING AN D PLACEMENT OF THE CATHE TER TUBING TO AVOID CUTS, NICK S, OR TEARS.

Medtronic, Inc. 710 Medtro nic Parkway NE Minneapolis, MN 55432 USA

+1 800 468-9710 USA/C anada +1 901 344-0 645 Inte rnational +1 800 468-9713 FAX USA /Canada +1 901 396-2698 FA X Internatio nal

medtronic.com manuals.medtronic.com

Standard,

Contoured , Ultra Small, an d Burr Hole

Standard,

Ultra Sma ll, and

M998361A001 A

2019 - 07

Pressure /Flow Test

Each PS Me dical®CSF -ow control va lve is individ ually tested t o ensure confo rmance with it s labeled pr essure/ ow characteristics. The testing performed by Medtronic Neurosurgery during the fabrication process to verify accepta ble perfor mance is quite r igorous. Ea ch valve is indi vidually tes ted for the abs ence of leakage , reux, and its pre implantatio n pressure. E ach valve is indi vidually tes ted for pres sure/ow cha racteris tics with st erile and pyroge nic-free water at t wo ow rates: 5 mL /hr and 50 mL/ hr.

The pres sure/ow cha racteris tics of a valve r elate to the dyn amic perfo rmance of a valve t hroughout t he range of physio logical ow r ates. It is not po ssible to veri fy the dynam ic perform ance charac teristic s with a stati c test that can b e perform ed in the opera ting room. Veri fying the pr essure/o w character istics of a va lve is an exten sive proced ure, which req uires an assem bled test app aratus, tes ting at multip le data point s, time to condu ct the testin g, and caref ul attentio n not to contamin ate the valve.

Medtronic Neurosurgery, therefore, does not recommend testing the valve for pressure/ow characteristics in the operating room.

CAUTION: SH UNT OBSTRUCTION M AY OCCUR IN ANY COMPONEN T OF A SHUNT SYSTEM AND SH OULD BE DIAGNOSED BY C LINICAL FINDINGS AND DI AGNOSTIC TESTING . VALVE FLUSHING CHARACTERI STICS MAY NOT BE ADEQUATE TO DIAG NOSE OCCLUSION OF CATHE TERS. SEE WARNINGS AND PR ECAUTIONS SECTI ON.

Shunt Assembly Patency Check

Shunt Pate ncy Check (Contoure d, Standard, and Burr Hole Valv es) (Figs 24,25, and 27)

a. Place inlet connector of valve into sterile isotonic saline. b. Dep ress and rele ase the valve do me repeated ly until uid  ows out of the di stal cathe ter. Observe t he slit

opening s near the dis tal end. All ope nings should a llow uid ow an d appear to open f or their comp lete length .

c. Gently r olling the slit o pening area be tween the th umb and fore nger will fre e slits if they d o not appear

to open completely.

d. Smoot h catheter wal l with thumb and f orenger so s lit openings a re in the close d position af ter

completion of the patency check.

Shunt Pate ncy Check (Butto n Valve) (Fig 28)

a. Usin g a 16-gauge blu nt needle adap ter, ll a syringe w ith sterile,  ltered, isot onic saline. b. Inser t blunt need le into the tubin g attache d to the proximal e nd of the valve. Usi ng gentle syr inge

pressu re, ush shunt wi th saline.

c. If salin e ows out of the di stal cathe ter end, the shun t is patent.

Shunt Pate ncy Check (Ultra Sm all Valve) (Fig 26)

a. Attach 16-gauge blunt needle adapter, tubing, and syringe to the valve inlet. b. Prel l valve and tubin g. c. Occlude inlet tubing. d. Depre ss dome. If uid  ows out of the pro ximal cathe ter, the valve is pate nt.

CAUTION: PART ICULATE MATTER IN THE TES T SOLUTION MAY AFFECT TE ST RESULTS AND PRODUCT PERFORMANCE.

CAUTION: E XCESSIVE FLUSHING PRE SSURE MAY CAUSE TEMPOR ARY DEFORMATION OF T HE CSF-FLOW CONTROL VALVE MEMBR ANE AND RESULT IN ABNORM ALLY LOW PRESSURE/FLOW TES T RESULTS.

PS Medical® Snap Shunt Assemblies

Description

PS Medical® Snap Shunt A ssemblies a re comprise d of several comp onents: a But ton Valve (Fig 20) or Ul tra Small Valve (Fig19), an i ntegral Snap A ssembly Ventr iculostomy R eservoir D ome, and an integ ral Peritone al Catheter. Both ass emblies, But ton and Ultr a Small, are availa ble in three pre ssure range s: Low-Low, Low, and Med ium. The radiopaque dot code on the valve indicates valve pressure ranges (Fig 22).

Pressu re/flow ch aracteris tics of the Ul tra Small and Bu tton Valves are s hown in Figure 39. The Snap Shu nt Assembl y, Button, with i ts ultra-l ow profile, is d esigned for u se especial ly in prematur e infants.

Compone nts of the Snap Sh unt Assembl y, Button, are: a bu tton valve; an i ntegral snap a ssembly vent riculosto my reser voir dome; an int egral perit oneal cathe ter, 90 cm, open end w ith wall slits; a p refill ada pter; and a 16-g auge blunt needle.

These slit openings are designed to provide protection from retrograde flow. They are not designed as pressure/ flow co ntrol valves, b ut add slight re sistance to f low. Maximum r esistance to f low at a const ant flow rate o f 20mL/ho ur is 2.0 cm H2O. The slit op enings are coa ted with grap hite during ma nufactur e to minimize the possibility of slitted surface adhesion during storage.

NOTE: Each Sn ap Shunt Assem bly must be us ed with a Snap Shun t Ventricular C atheter for a co mplete Flow Control S hunt. A Snap Ass embly Tool is avai lable separa tely to simplif y the “snap” pro cedure.

The Snap Shunt Assemblies incorporate a completely unitized “snap-together” radiopaque silicone elastomer reser voir design . The Snap Shunt A ssembly res ervoir pr ovides dire ct access to t he ventricles for injection, sampling and drainage. The integ ral Periton eal Catheter, Op en End with Wall S lits, minimi zes potentia l catheter o cclusion. Ea ch shunt valve is individually tested to ensure conformance with its labeled pressure/flow characteristics.

PS Medic al®Snap Shun t Ventricular Cath eter (available s eparately, see cat heter sectio n)

Indications

Snap Shunt A ssemblies a re component s of a shunt sys tem, designe d to provide cont rolled CSF f low from the ventric les of the brai n into the peri toneal cavit y. A complete shun t provides di rect access t o the lateral cer ebral ventric les. The dis tal peritone al catheter, wi th its open end a nd wall slits, i s not recommen ded for placem ent into the right atrium of the heart.

The But ton Snap Shunt As sembly is rec ommended fo r use in prematu re infants in w hom the small va lve and small diam eter cathet er is indicate d. The Snap Shunt A ssembly, Ultr a Small is recom mended for us e in infants an d childr en in whom a small si zed valve is indi cated.

Instructions for Use

120

100

5203040

Medium Pressure

Low Pressure

Low-Low Pressure

Surgical Procedure

A variet y of surgica l techniques m ay be used in plac ing the Snap Shun t Assemblie s. The surgic al technique, t he site of pla cement and the s tyle and pre ssure of the pro duct used a re at the discre tion of the sur geon, based o n his evaluation of patient needs.

Both the B utton Valve and t he Ultra Small Val ve are implante d with the fl at surface ad jacent to the per icranium. Placemen t in a surgicall y created sub galeal pocket , not under the s calp incisio n, is recommend ed. The upper surf aces of the valve s are marked wi th a radiopaqu e arrow pointe d distally in t he directi on of CSF flow. Th e Ultra Small Valve ma y be sutured to a djacent tissu e by passing a sut ure through th e Dacron-re inforced f lange.

NOTE: The Snap S hunt Assemb ly must be use d with a Snap Shunt Ven tricular Ca theter for a com plete shunt.

Ventricular Catheter Placement

A subgale al pocket mus t be formed wi th appropri ate depth to accep t the extra cranial por tion of the bas e, reservo ir and valve. Imp lantation of t he ventricul ar catheter is t he recommen ded final st ep in the shuntin g procedure, m inimizing lo ss of CSF during surgery.

stainl ess steel st ylet, pack aged with eac h catheter, is des igned to faci litate intro duction of t he catheter i nto the lateral ve ntricle. The c atheter is pa ckaged with t he stylet i nserted in t he lumen. Once th e catheter is p laced in the proper p osition in th e ventricle, th e stylet is wi thdrawn fr om the cathet er.

CAUTION: D O NOT PUNCTURE THE SILI CONE RESERVOIR DOME W ITH THE STYLET DU RING CATHETER PLACEMENT. THIS M AY RESULT IN LEAKAGE THROUG H THE DOME

Assembly of the Shunt

After t he ventricul ar catheter ha s been placed, t he reservo ir base may be snap ped togethe r with the shunt assemb ly integral re servoir do me. A Snap Assemb ly Tool is availabl e separatel y to simplify a nd expedite t he snap proced ure. Slip the “pro ngs” of the tool u nder the rese rvoir base; t hen, snap the dom e onto the base (F ig 12). After the dome a nd base are snap ped togethe r, the reservoi r is placed in a 6 mm bu rr hole or twi st drill hole.

WARNING: DO NOT D ISASSEMBLE THE RESE RVOIR AND BASE ONCE THE Y ARE SNAPPED TOGETH ER. THE RESERVOIR AN D BASE ARE DESIGNED FO R “ONE-TIME ONLY” SNAP ASSEM BLY. METICULOUS C ARE MUST BE TAKEN DURING AS SEMBLY TO ASSURE COMPLETE ATTACHM ENT AND TO PREVENT DAM AGE TO PLASTIC COMPONENT S. DISASSEMBLY AND REA SSEMBLY, AND/OR DAMAGING OF THE PL ASTIC COMPONENT S DURING ASSE MBLY CAN RESULT IN UNWANTED DISCON NECTION OR IN LEAK AGE OF THE ASSEMBLY.

Injec tion into the Rese rvoir

CAUTION: LOW T EAR STRENGTH IS CHAR ACTERISTIC OF MO ST SILICONE ELAST OMER MATERIALS. CAR E MUST BE TAKEN ON INSER TION AND REMOVAL OF THE NEE DLE.

The dome of the ventriculostomy reservoir is designed to allow multiple punctures. Inserting the needle at various locations to avoid repeated punctures at a single point on the dome is recommended. Product performance tests c onducted by M edtronic Ne urosurger y indicate tha t each reser voir can toler ate up to 100 punc tures with a 25-gau ge or smaller no ncoring need le. The units we re filled wi th distille d water and pres surized to 40 c m H2O. Actual p roduct per formance m ay vary depen ding upon inje ction tech nique, needl e type and size.

Injec tion into the Ultra S mall ValveCAUTION: THE BUT TON VALVE DOES NOT INCLUDE AN INJECTABLE CENTRAL RESERVOIR .

The need le should be ins erted at an angle no greater than 45° from t he scalp or bas e of the valve. If th e valve will be punc tured sever al times, inse rting the ne edle at variou s locations i s recommende d in order to avoi d repeated punct ures at a single p oint on the dome . The catheter t ubing and occ luder are not to be u sed as injection sites.

CAUTION: INS ERTION OF THE NEEDLE AN D PUNCTURE OF THE PRES SURE/FLOW CONTROL M EMBRANE IS VERY UNLIKELY, BUT CAR E SHOULD BE TAKEN NOT TO ALLOW THIS . PUNCTURE OF THE MEMB RANE MAY AFFECT THE PRES SURE/FLOW CHARAC TERISTICS OF THE VALVE .

Valve Flushing

CAUTION: TH E BUTTON VALVE DOES NOT INCLU DE OCCLUDERS OR A CENT RAL RESERVOIR FOR SE LECTIVE FLUSHING.

Percut aneous depr ession of the U ltra Small Valve d ome will forc e CSF out of the va lve in both prox imal and dist al direc tions. To selec tively f lush, depres s and occlude e ither the pro ximal tubin g or valve occlu der by percut aneous finger pressure, then depress the valve dome. This will cause fluid to flow in the direction opposite the occluded side of the valv e. If there is not iceable resi stance to dom e compressi on, the cathe ter to be flus hed may be occlu ded.

Peritoneal Catheter Placement

A variet y of surgica l techniques m ay be used in plac ing the dista l catheter in to the periton eal cavity. Th e site of placeme nt is at the discr etion of the su rgeon. The ca theter lengt h on the Snap Shunt A ssembly, But ton and Snap Shunt As sembly, Ultra Sm all is 90 cm. Both a ssemblies f eature peri toneal cathe ters with wal l slits at the op en distal e nd. If cathet er wall slits ar e not desired, t he distal end m ay be trimmed. T he catheter s hould be chec ked for patenc y at the time of su rgery.

A subcut aneous cath eter passer i s available for t unneling of th e distal cat heter. The PS Medical®Subcutaneous

NOTE: Levels depicted are median values. The tolerance range of the median values is

105

+/- 25 mm H

O. Low-Low Pressures are

within +/- 10 mm H2O at 5 mL/hr and +/- 20 mm H2O at 50 mL/hr . Every PS Medical valve is tested for its

system at the time of manufacture to assure

consistent high quality. All valves must conform to labeling specications in these tests. Subsequent testing of the valve may give dierent results depending on test conditions

and condition of the valve.

Cathet er Passer, 38 or 60 cm i n length, is rec ommended.

Shunt Pate ncy Check

1. Atta ch the transl ucent prefi ll adapter to the i nlet of the res ervoir dome ( Fig40).

2. Usi ng the 16-gaug e blunt needl e adapter, fill a s yringe wit h sterile, f iltered, is otonic salin e.

3. Inser t the blunt ne edle adapter i nto the port o f the prefil l adapter, and using g entle syrin ge pressure, flush s hunt assembl y with the sali ne.

4. If the s aline flows o ut of the dist al catheter en d, the shunt ass embly is paten t.

NOTE: Pressure/ow test instructions are available upon request from the Medtronic Neurosurgery Customer Service department.

PS Medical® CSF-Unitized Shunts

Description

A CSF-Un itized Shunt i ncludes a CSF- Flow Control Val ve with integr al ventricu lar and distal c atheters, a disposable Quick-Release Introducer, and a Right Angle Clip. CSF-Unitized Shunts are available with low-low, low, or mediu m pressure va lves (Ultra Sma ll and Button Val ves); and low, medium, an d high-pre ssure valves (Contoured, Standard, and Burr Hole Valv es). A radiopaque d ot code on the val ve indicates v alve pressur e. Pressure/ow characteristics are shown in gures 21 and 22.

A variet y of PS Medical®component s have been comb ined to create u nique shunt sy stems. Refe r to the CSF-Flo w Control Valve, Ventricular Catheter, and Distal Catheter sections for descriptions of these shunt components.

Metal-free implantable components ensure distortion-free CT or MR imaging. Radiopaque markings indicate valve pressure, ow direction and valve-to-catheter approximation. The catheters are kink and compression resistant. No component connections are required.

NOTE: The pr essure/o w character istics dep icted in gu re 22 pertain to the individual valve. Although minimal, the integ ral periton eal cathete r will increas e resistanc e to ow as compare d to an individu al CSF-Flow Co ntrol Valve. The ma ximum addit ional resist ance to ow at a cons tant ow rate o f 20 mL/hr is 2 cm of H2O for open -end distal c atheters a nd 3.5 cm H2O for clos ed-end dis tal cathete rs.

Indications

CSF-Un itized Shunt s are designe d as integrate d CSF-Flow Cont rol Shunts f or use in shunti ng cerebrosp inal uid from th e lateral ventr icle of the brai n into the peri toneal cavit y. The small unit ized shunt is re commended fo r use with pat ients (e.g. infa nts) in whom a small sized val ve is indicate d.

Instructions for Use

Surgical Technique

A variet y of surgica l techniques m ay be used in pl acing the CSF- Unitized Shu nts. The intracranial ventricular catheter length a nd peritonea l catheter len gth are at the discretion of the surgeon. The Contoured, Ultra Small, Button, and Standard Valves are p laced with the  at surface adjacent to the pericranium. The Burr Hol e Valve is designe d to t into a formal b urr hole. The up per surfa ces of the Standard, Contoured, Button, and Ultra Sma ll Valves are mark ed with a radiopaque arrow pointed distally (in the dire ction of CSF  ow). Suture holes are provi ded on the Bur r Hole Valve anges to accommodate valve-to-tissue anchoring. The Contoured, Standard, and Ultr a Small Valves may be s utured to adja cent tissue by p assing a sutur e through the f abric-reinfo rced anges.

CAUTION: USE O F SHARP INSTRUMENT S WHILE HANDLING THESE DE VICES CAN NICK O R CUT THE SILICONE ELASTO MER, RESULTING IN LEAK AGE AND NECESSITATING SHUNT R EVISION. CARE MU ST BE TAKEN WHEN CLOSING INCIS IONS TO ENSURE THAT THE VALVES ARE N OT CUT OR NICKED BY SUTU RING NEEDLES.

Ventricular Catheter Placement

A disposable quick-release ventricular catheter introducer is supplied with each unitized shunt (Fig41). The introd ucer tip is desi gned for inse rtion into th e ventricula r catheter via t he ow hole clo sest to the val ve (Fig42).

The tip is inserted into the catheter ow hole; then, catheter and introducer are held rmly together and inserted into the ventr icle. When th e desired cat heter loca tion is achiev ed, the shaf t grip is held r mly as the st ylet grip is p ulled back app roximately 1.5 c m, releasing t he cathete r from the int roducer (Fig 43). The intro ducer may now be w ithdrawn from the ventricle.

The righ t angle clip on th e ventricul ar catheter m ay be used to ben d the ventric ular cathet er to an approxi mate 90˚ angle whe re it exits t he twist dr ill or burr hol e (Fig44). The clip may be use d as a marker for p lanned dept h of catheter inser tion by slidin g it the desire d distance f rom the prox imal tip of the c atheter pri or to insert ion surgeo n does not wish t o use the clip it m ay be easily rem oved prior to in sertion o f the ventric ular cathet er.

After t he catheter i s located pro perly in the ve ntricle, th e extracr anial port ion of the cat heter is pres sed into the sp lit tubular s egment of th e clip to form a ri ght angle ben d (Fig 46). Avoid stretc hing the cath eter when it is p ressed into the clip. I t is recommen ded that the ri ght angle clip b e secured to a djacent tiss ue by passing su tures thro ugh the two suture anges on the sides of the clip (Fig44).

If the right angle clip is not use d with the Unitize d Shunt, it is recommended that the surgeon trim the rim of the b urr hole to provid e a beveled notch where th e catheter emerge s and curves to lie adjace nt to the skull. A subgale al pocket mus t be formed wi th appropri ate depth to ac cept the ext racranial po rtion of the ventric ular cathet er and the valve.

Injec tion into the Valve

The dome on the Standard, Contoured, Ult ra Small, and Burr H ole Valves is desi gned to allow injection via a 25- gauge or smalle r noncoring ne edle (Fig23, see valve s ection). The r m polypropylene base is designed to help pre vent complete penetration of the valve.

CAUTION: THE BUTTON VALVE IS NOT DESIGN ED TO ALLOW INJECTION WITH A NEEDLE. A SEPARATE RESERV OIR OR ANTECHAMBER IS REQUIRED FOR CSF ACCESS .

The need le should be ins erted at an angle no greater than 45˚ from the scal p or base of the va lve. If the valv e will be punc tured several times, inserting the needle at various locations is recomm ended in order t o avoid repeate d punctures at a single point on the dome. The cath eter tubing an d occluder are n ot to be used a s injection sites.

CAUTION: SHUNT OBSTRUCTION MAY OCCUR IN ANY CO MPONENT OF A SHUNT SYST EM AND SHOULD BE DIAGNOSED BY CLINICAL FINDINGS AND DIAGNOST IC TESTING. VALVE FLUSHING CHAR ACTERISTICS MAY NOT BE ADEQUATE TO DIAG NOSE OCCLUSION OF C ATHETERS. SEE WARNINGS AND PREC AUTIONS SECTION.

Distal Catheter Placement

Site of placement is at the discretion of the surgeon. The integ ral distal c atheter of the U nitized Shun t may have an open or

closed t ip. The close d-end cath eter has a bullet- shaped tip. Th e shape of the tip i s designed for b oth cardiac a nd peritoneal placement. The distal catheter with ope n end is not recom mended for c ardiac placement.

A variet y of surgica l techniques m ay be used in placing t he distal ca theter into th e peritoneal cavit y, or other CSF dive rsion site. Th e site of placement is at the discretion of the surgeon. The cath eter should be c hecked for pa tency at the time o f surgery. See t he Catheter Pa tency Check in t he Catheter s section o f this insert for directions.

If a subcutaneous tunneling device is needed for place ment of the dis tal cathete r it is recommended that the PSMedical® reus able or dispos able Subcut aneous Cath eter Passer be u sed.

Stylet grip

16-gauge Blunt Needle Adapter

30 cc Syringe

Twist drill or

burr hole

Right angle

Ventricular

catheter

CSF-ﬂow control valve, contoured

Reservoir Dome

Prell

Adapter

Stainless steel shaft

clip

Bend catheter;

shaft grip

Button Valve

(Fig45). If the

Catheter

Suture

pyroge nic-free water at t wo ow rates: 5 mL /hr and 50 mL/ hr. The pres sure/ow ch aracteri stics of a val ve relate to the d ynamic per formance of a v alve throug hout the rang e of

physiol ogical ow ra tes. It is not po ssible to veri fy the dyn amic perfo rmance char acterist ics with a st atic test th at can be per formed in th e operating r oom. Verify ing the pres sure/ow ch aracteri stics of a val ve is an exten sive procedu re that req uires an asse mbled test ap paratus, te sting at mult iple data po ints, time to co nduct the te sting, and c areful attention not to contaminate the valve.

Medtronic Neurosurgery, therefore, does not recommend testing the valve for pressure/ow charac teristic s in the operat ing room.

Unitize d Shunt Patency Ch eck

Shunt Patency Check (Contoured, Standard, and Burr Ho le Valves) Prior to im plantatio n, the surgeo n may utilize the f ollowing te st to verif y patency of t he shunt:

Place the in let holes of Ven tricular Ca theter i

Depress and release the valve dome repeatedly until uid ows out of the Peritoneal Catheter. If uid ows out of

the

CAUTION: PART ICULATE MATTER IN THE TES T SOLUTION MAY AFFECT TE ST RESULTS AND PRODUCT PERFORMANCE.

CAUTION: E XCESSIVE FLUSHING PRE SSURE MAY CAUSE TEMPOR ARY DEFORMATION OF T HE VALVE MEMBRANE AND RESULT IN ABNORMALLY LOW PRESSURE/FLOW PERFORMANCE.

Shunt Pate ncy Check (Butto n Valve Fig 48)

Shunt Pate ncy Check (Ultra Sm all Valve Fig 49)

Peritoneal Catheter, the shunt is patent.

a. Att ach 18-gauge b lunt needle ad apter to syri nge and inser t blunt needl e into most dis tal ow hole of th e

ventricular catheter. b. Using ge ntle syring e pressure, u sh shunt with st erile isoton ic fluid. c. If salin e ows out of the di stal cathe ter end, the shun t is patent.

a. Att ach 18-gauge b lunt needle ad apter to syri nge and inser t blunt needl e into most dis tal ow hole of th e

ventricular catheter. b. Prell shunt. c. Occlude ventricular catheter. d. Depre ss dome. If uid  ows out of the int egral perit oneal cathet er, the valve is pate nt.

nto lter ed sterile is otonic uid (F ig47).

PS Medical®Catheter Connectors

Description

PS Medic al® Catheter Connector, Straight

The Catheter Connector, Straight (Fig Medical®ventricular and distal catheters.

50a

), is a nylon or s tainless st eel connec tor designed f or use with PS

PS Medic al® Catheter Conn ector, Right Angl e

The Catheter Connector, Right Angle (Fig catheters.

50b

), is a nylon con nector de signed for us e with PS Medical®ventricular

PS Medic al® Catheter Connector, 3-Way

The Cath eter Connec tor, 3-Way (Fig50c), is a polypropylene and silicone elastomer connector designed to connect two PS Medical®ventr icular cath eters to one PS Medic al®CSF-ow control valve inlet connector.

Indications

PS Medic al® Catheter Connector, Straight

The Catheter Connector, Straight, is indicated for use wh en distal or ve ntricular c atheter revisio n is required , or to connect a v entricular cathet er to the inlet po rt of a PS Medical®valve.

PS Medic al® Catheter Conn ector, Right Angle

The Catheter Connector, Right Angle, is indica ted for use to ang ulate the ventr icular cathet er to a 90° angle (nom inal) where it e xits the twi st drill or bur r hole.

PS Medic al® Catheter Connector, 3-Way

The Cath eter Connec tor, 3-Way, is indicate d for use when two PS Medical®ven tricular ca theters are c onnected to one PS Medical®CSF-Flow Control valve.

Instructions for Use

The surg ical techniq ue employed in t he use of cathe ter connectors is at the discretion of the surgeon.

Depress Valve Dome

Fluid Line

Sterile Isotonic Fluid

Ventricular Catheter

Button Valve

PS Medical®Disposable Subcutaneous Catheter Passer, 38 and 60 cm

Description

PS Medical® disposable subcutaneous catheter passers are disposable surgical instruments. They are available in two len gths, 38 cm and 6 0 cm, and consis t of two components:

1. A tubu lar shaft wit h polypropy lene T-shaped

handle.

2. An obt urator with bu llet-shaped t ip.

The instruments are designed as malleable subcutaneous tunneling devices for passing cerebrospinal uid shunt catheters (Fig 51).

Indications

The PS Medical®disposable subcutaneous catheter passers are used f or the placem ent of the peri toneal cath eter component of a cerebrospinal uid shunt or for the placement of the lumboperitoneal catheter.

Instructions for Use

The surg ical techniq ue employed in t he use of the Disposable Subcutaneous Catheter Passers is at the discretion of the surgeon. The surgeon is advised to ensure th at the cathet er will pass thr ough the inst rument prio r to beginning t he procedur e. The tubular sh aft is malleab le and may be hand -formed by th e surgeon as ind icated for th e operative p rocedures. W hen the instr ument is passe d subcutane ously, the obtu rator must be i nserted in t he tubular shaf t and secur ed in the handle by sn apping the ob turator’s loc king tip into po sition. Af ter removal of th e handle and obt urator, the catheter may be hand-fed through the lumen of the tubular shaft.

The obtu rator also in cludes a cat heter att achment sit e for attac hment of an op en ended dis tal cathet er. Attachme nt of the cat heter to the ob turator al lows cathe ters of appr opriate I.D. (in ner diamete r) to be pulled th rough the pa sser shaf t.

50a

50b

50c

18-gauge Blunt Needle Adapter

30 cc Syringe (lled with sterile

isotonic saline solution)

18-gauge Blunt Needle Adapter

PS Medical®Products

How Supplied

PS Medical®CSF-o w control prod ucts are pa ckaged STERILE and NON- PYROGENIC. The encl osed produc t is designe d for single pat ient use only. Do not re- use, re-pr ocess, or re- sterilize th is product . Re-us e, re-proce ssing or re-s terilizat ion may comprom ise the struc tural inte grity of the d evice and/or cr eate a risk

of contam ination of the d evice, which co uld result in p atient injur y, illness, or dea th. Medtro nic Neurosur gery is not re sponsible fo r the perfo rmance of any pro duct that ha s been rester ilized. Do not use i f package has b een opened or d amaged.

Special Order Products

If this ins tructi ons for use ac companies a s pecial ord er produc t, there may be d ierence s in the physic al charac teristic s betwe en the produ ct and prod uct desc ription in t his product package insert. Thes e dierenc es will not a ect the sa fety or ecac y of the spe cial order pr oduct. Sp ecial orde r product s may be suppl ied sterile or non-sterile as indicated on the produc t package l abel. Non-s terile pr oduct s must be cle aned and ste rilized p rior to use.

Contraindications

Shuntin g of CSF into the r ight atrium, p eritoneal c avity, or oth er areas of the bo dy should not b e carried o ut if there is infec tion in any are as in which the v arious comp onents of th e shunt syste m will be implan ted. These i nclude infec tions of the s calp and othe r skin area thro ugh which the s hunt syste m will traver se, the mening es and cerebr al ventricles, peritoneum and intraperitoneal and retroperitoneal organs, pleura and blood stream. CSF shunting is contra indicated i f there is infe ction pre sent in any area o f the body. Addit ionally, shunt ing into the atr ium of patien ts with congenital heart disease or other serious cardiopulmonary abnormalities is contraindicated.

Polypropylene handle

Stainless steel shaft

Patient Education

It is the re sponsibilit y of the physic ian to educate t he patient an d/or represen tative(s) regar ding CSF shunt ing. This shou ld include a des cription o f the complica tions assoc iated with imp lantable shu nt systems, an d an explanation of potential alternative products and treatment s.

Warnings and Precautions

The appr opriate prod uct, size, pr essure, or per formance r ange must be ch osen for the sp ecic patie nt’s needs, based on d iagnostic t ests and phys ician exper ience. Produc t labeling sp ecies app licable prod uct perf ormance levels or ranges.

Avoid cont acting imp lantable pro ducts wit h lint, glove talc , oily residu e from skin, oil b ased soaps, s ynthetic detergents or other surface contaminants.

Cathet ers with Bio Glide can abs orb any mater ial that is solu ble in the hydra ting soluti on, or is water-s oluble. For thi s reason, u se only ster ile, filter ed, isotonic s aline to hydra te the cathet ers, and hydra te only in their p ackaging t rays. Uptake of o ther solubl e materials int o the BioGlid e layer may resul t in adverse pa tient reac tions to the im plant.

When dry, avoid elongating, stretching or twisting of catheters with BioGlide. Improp er handling or us e of instrum ents when imp lanting shunt c omponents ma y result in the cu tting, sli tting,

crushi ng, or breakin g of component s. Such damage m ay lead to a loss of sh unt integrit y, and necessi tate premature surgical revision of the shunt system.

Care mus t be taken to ensu re that parti culate conta minants are no t introduce d into shunt comp onents duri ng preimplantation testing or handling. Introduction of contaminants could result in improper performance (overdrai nage or underd rainage) of the sh unt system. Pa rticulate m atter that en ters the shunt s ystem may also hold pressure/ow controlling mechanisms open, resulting in overdrainage.

In securing the ventricular and distal catheters to the valve connectors, the ligatures encircling the tube should be securely, but not too tightly fastened, lest they eventually cut through the silicone tubing .

Care mus t be taken in the ro uting of cath eters to prev ent kinking an d needless ab rasion along t heir course. T he rim of the t wist drill o r burr hole may be t rimmed to pro vide a beveled n otch where the v entricular c atheter emerge s and is curve d to lie adjacent to t he skull.

“Small” s ize catheter s have thinner w alls and lower over all strengt h as compared w ith “Standar d” size cathe ters. These ch aracteri stics resu lt in a comparat ively greater p otential fai lure (fract ure) rate and, the refore, shor ter life expec tancy for “ Small” size ca theters. Phy sicians who im plant “Small ” size cathete rs for cosmet ic reasons mus t acknowledge the potentially higher rate of catheter revision and weight this against the cosmetic benet.

”Snap shun t“-type pr oducts may d isconnec t at the plastic s nap junctio n if they are: 1) damage d prior to conn ection; 2) connected, disconnected and reconnected; or 3) not completely connected during implant. Occipital placement has been associated with a low rate (<0.3%) of shunt component disconnections. The surgeon should evaluate this potential risk in determ ining the appr opriate impl ant placement l ocation. Dis connecti on at the plast ic snap junct ion may result in o ver- or underdrainage, and will necessitate surgical revision to replace the plastic snap components.

Patient s with hydroce phalus shunt s ystems must b e kept under clo se observ ation in the pos toperativ e period for signs or symptoms suggesting shunt malfunction. Clinical ndings may indicate infection, shunt obstruction or overdrainage of CSF.

Clott ing around the a trial port ion of the cath eter may lead to em bolization o f the pulmonar y arteria l tree with resulting cor pulmonale and pulmonary hypertension.

Disconnected shunt components may further migrate into the heart, or into the peritoneal cavity.

Shunt systems may fail due to mechanical malfunction, leading to underdrainage or overdrainage. Malfun ction or obs tructio n of the shunt sys tem may lead to sig ns and sympto ms of increase d intracran ial pressur e

if the hydr ocephalus is n ot compensat ed. In the infan t, common ndi ngs are increa sed tension of t he anterior fontanelle, congestion of scalp veins, listlessness, drowsiness and irritability, vomiting, and nuchal rigidity. Other children and adults will develop signs and symptoms commonly associated with increased intracranial pressure such as headaches, vomiting, blurring of vision, nuchal rigidity, deterioration of consciousness and variable abnormal neurological ndings.

Overdr ainage of CSF may p redispose d evelopment o f subdural hem atoma or hygroma o r collapse of th e lateral ventricular walls leading to obstruction of the ventricular catheter.

If the vent ricular cat heter become s bound to the ch oroid plexu s or adjacent br ain tissue by br ous adhesio ns, it is sugges ted that the ca theter shoul d not be removed f orcibly. It is sug gested that gentle rotation of the catheter may help to f ree it. It is adv ised that the c atheter be lef t in place rat her than risk in traventric ular hemorrh age which forcible removal may cause.

Subcut aneous cath eter passer s can break at we lds or compone nt assembly po ints, or due to e xtreme def ormation of the mall eable shaft . Sudden break age can lead to t rauma of tissue s or organs, and d amage to the shun t syste m. Instrumen ts must be ins pected pri or to use to ensur e continued in tegrity an d function ality. Dispos able instr uments must n ever be reused , or injury to th e patient or phy sician is poss ible.

Complications

Complications associated with ventriculoatrial and ventriculoperitoneal CSF shunting systems may be similar to those e xperience d in any surgica l procedure c arried out un der local and /or general ane sthesia. The se include react ions to drugs an d anestheti c agents, ele ctrolyt e imbalancean d excessive bl ood loss, par ticularly i n infants. A patien t may rarely exh ibit a reacti on due to sensit ivity to the i mplant.

Use of non-ltered or non-controlled uids for preimplantation testing may result in improper valve performance and nece ssitate valve r evision. Dev ices must be ha ndled in contr olled hospit al environme nts only to pre vent the introd uction of pa rticles, b ers or other co ntaminant s into the valve.

Use of shar p instrumen ts while hand ling these dev ices can nick o r cut the silico ne elastomer, re sulting in leak age and nece ssitating va lve revision. C are must also b e taken when clo sing incisio ns to ensure that t he valves are no t cut or nicked by suture needles.

In CSF shunting procedures, the most common complications are due to obstruction of the system as described under th e “Warnings and P recaution s”section i n this produc t package ins ert. Obst ruction may o ccur in any compone nt of the syst em due to pluggin g by brain frag ments, bloo d clots, and/or t umor cell aggr egates at some point alo ng its cours e. Obstruc tion may also oc cur becaus e of separatio n of the syste m components o r kinking and/or coil ing of the cath eter. This may pred ispose migr ation of the vent ricular cat heter into the l ateral ventr icle and the dis tal cathet er into the hear t and pulmona ry arteria l tree, the per itoneum, or oth er struct ure in which the cath eter is implan ted. As noted pr eviously, grow th of the infa nt or child may ca use the dista l catheter to b e withdr awn from the at rium into the in ternal jugul ar vein or from th e peritoneu m into tissue pla nes where the uid cannot be absorbed.

There are other potentially serious complications. Local and systemic infections are not uncommon with shunting procedures. Usually, they are due to organisms inhabiting the skin, particularly Staphylococcus epidermidis. Other p athogens cir culating in th e blood strea m may colonize th e shunt and, in the m ajority of p atients, re quire its removal.

In 1973, Robertson et al. summarized the incidence of infection in ventriculoatrial and ventriculoperitoneal shunts repor ted up to that tim e. The incidenc e of infecti on in ventric uloatrial sh unting varie d from 7 to 31%. Infec tion in ventric uloperit oneal shunti ng occurre d in 5 to 10% of the pati ents in most o f the repor ts. Becau se ventricu loatrial shu nting predisposes the spread of bacteria into other organs, ventriculoperitoneal shunting is considered less devastating.

In 1993, Kestle e t al. report ed signica nt reduct ions in infection (less than 4%) with the use o f antibioti cs, short duration of surgery (surgical experience) and control of the operating room environment (e.g., designated operating room, lim ited perso nnel and tra c, covered sk in surface s). The article s tates that r esults can a lso be obtain ed without the use of antibiotics, but with rigorous perioperative control of the environment.

Using pro phylactic a ntibiotic s in shunted pat ients is some what controve rsial as their u se may predisp ose infec tion by more re sistant orga nisms. There fore, the dec ision to use anti biotics pr ophylacti cally rest s with the atte nding physician and/or surgeon.

Shuntin g into the perit oneum may fail b ecause of inve stments of t he catheter i n loops of bowel o r in the greater omentum. Perforation of the bowel by the peritoneal catheter with subsequent development of peritonitis has been described.

CSF overd rainage may re sult in excessi ve reducti on of CSF pressure and predispose the development of a subdur al hematoma or hyg roma, and exce ssive reduc tion of ventri cular size lead ing to obstru ction bec ause of impinge ment of the vent ricular walls o n the inlet hol es in the cathe ter. rdrainage. I n the infant, this excessive pressure reduction will cause marked depression of the anterior fontanelle, overriding of cranial bones and may convert communicating into obstructive hydrocephalus.

The incidence of epilepsy after ventricular shunting procedures has been reported. This study al so indicated t hat the incidence of seizures increased with multiple catheter revisions.

Returned Goods Policy

Produc ts must be re turned in un opened pac kages, with m anufact urer’s seals in tact, to be ac cepted for re placement or credi t, unless re turned due to a c omplaint of pr oduct def ect or misla beling. Det ermination o f a product d efect or mislab eling will be ma de by Medtron ic Neurosur gery, which de terminati on will be nal. P roducts w ill not be accepte d for replacem ent or credi t if they have bee n in the posse ssion of the cu stomer for m ore than 90 days .

Warra nty

A. Stand ard Limi ted Warran ty. Medtronic Neurosurgery warrants to the original end user purchaser (“Purchaser”) that

the encl osed singl e use impla ntable pro duct (“Pr oduct ”) purc hased by Pur chaser, at the t ime of deli very to Pur chaser, shall b e subst antially f ree from d efect s in materia l and workm anship. Med tronic Ne urosurg ery makes n o warrant y (expres s, implied , or stat utory) fo r Produc ts that are m odifie d (except as ex pressly c ontempla ted herein) or s ubject ed to unusua l physical s tress, misuse, improper operation, neglect, improper testing, use in combination with other products or components other than those for whic h the Produ cts were d esigned, o r use in any man ner or medi cal proce dure for wh ich the Pro ducts ar e not indic ated.

B. Remedy. Purchaser ’s exclusive remedy and Medtronic Neurosurgery’s sole liability for breach of the foregoing warran ty shall be, at Me dtronic Neur osurgery ’s sole option an d election , to replace the Pr oduct or cre dit Purchas er for the net am ount actual ly paid for any su ch Product ; provided tha t (i) Medtronic N eurosurger y is notie d in writing wi thin ninet y (90) days after Pu rchaser’s re ceipt of the Pro duct that suc h Product fa iled to conform, including a detailed explanation in English of any alleged nonconformity; (ii) such Product is returned to Medtr onic Neurosu rgery with in ninety (90) day s after Purc haser’s recei pt of the Produc t F.O.B. 125 Cremona Drive, Go leta, Calif ornia 93117, U.S.A. or as oth erwise de signated by Med tronic Neur osurgery; a nd (iii) Medtro nic Neurosurgery is reasonably satised that the claimed nonconformities actually exist. Except as expressly provided in this par agraph, Purc haser shall no t have the right to r eturn Produ cts to Medt ronic Neuros urgery wit hout Medtronic Neurosurgery’s prior written consent.

C. Excl usion of Oth er Warranti es. EXCEPT FOR THE LI MITED WARRANTY PR OVIDED IN (A) ABOVE, MEDTRONIC NEUROSURGERY GRANTS NO OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED, AND MANUFACTU RER SPECIFICALLY DISCL AIMS THE IMPLIED WARRAN TIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC NEUROSURGERY NEITHER ASSUMES NO R AUTHORIZES ANY OTH ER PERSON TO ASSUME AN Y OTHER LIABILITIES ARI SING OUT OF OR IN CONNECTI ON WITH THE SALE OR USE OF ANY P RODUCT.

PS Medical® CSF-Flow Control Products

Instructions for use

Caution: consult accompanying documents.

Use by

Sterilization: Ethylene-Oxide Gas

Do Not Reuse

Package Contents

Reference Number

Lot Number

Caution: For U.S. audiences only.

CAUTION: U. S. federal law restricts this device to sale by or on the order of a physician.

Manufacturer

PS Medical®, Opus®, Rivulet® and BioGlide® are registered trademarks of Medtronic, Inc.

PS Medical®Ventricular Catheters

PS Medical® Barium-Impregnated Ventricular Catheter PS Medical® Ventricular Ca theter wit h BioGlid e PS Medical® Standard Ventricular Catheters PS Medical® Small Ventricu lar Cathe ters PS Medical® Translucent Ventricular Catheter PS Medical® Translucent Ventricular Catheter with Radiopaque Stripe PS Medical® Slotted Ventricular Catheter PS Medical® Innervision Ventricular Catheter PS Medica l® Flanged Ventricular Catheter PS Medical® Snap Assembly Ve ntricula r Cathete r PS Medical® Pliant Ventricular Catheter PS Medical® Ventriculostomy Ventricular Catheter PS Medical® Opus® Ventricular Catheter with Opus® Stylet

PS Medical® Distal Catheters

PS Medical® Barium-Impregnated Distal Catheter PS Medica l® PeritonealCatheter wi th BioGlid e PS Medical®Small Dista l Catheter PS Medical®Distal Cathet er with Wal l Slits PS Medical®Translucent Distal Catheter

PS Medical®Pliant Distal Catheter PS Medical®Reduced Tip Distal Catheter PS Medical®Open End Dista l Cathete r PS Medical®Closed End Dist al Cathete r

PS Medical® CSF-Flow Control Valves PS Medical® CSF-Ventriculostomy Reservoirs

PS Medical® Ventriculostomy Reservoir PS Medical® Unitized Ventriculostomy Reservoir PS Medical® Snap Assembly Ventriculostomy Reservoir

PS Medical®CSF-Shunt As semblies & Sh unt Assemb ly Kits

PS Medical®Shunt Assembly with BioGlide

PS Medical® Snap Shunt Assembly

PS Medical®Snap Shunt Ass embly wit h BioGlid e

PS Medical® CSF-Unitized Shunts PS Medical® Catheter Connectors

PS Medical®Catheter Connector, Straight PS Medical®Catheter Conn ector, Righ t Angle PS Medical®Catheter Conn ector, 3-Way

PS Medical® Disposable Subcutaneous Catheter Passer, 38 and 60 cm

CSF-Flow Contro l Valve Pressure/Flo w Test

Catheter connection

Polypropylene obturator tip

+ 1 hidden pages

Medtronic 20046 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual