Medtronic 276081 Instructions for Use

PS Medical® Ventricular Catheters

Radiopaque

Outlet ports

Radiopaque mark

Radiopaque Pressure Dot

Silicone membrane valve

Silcone dome

Manometer

Connect product here

Syringe

Pressure (mm H

NOTE: Levels depicted are median values.

O of these median values when tested

Subsequent testing of the valve may give

Twist Drill or Burr Hole

Description

PS Medic al® Ventricul ar Catheter s are available in a v ariety of co nguration s: small and sta ndard sizes; di erent length s; with or witho ut anges; bar ium impregna ted; transluc ent or translu cent with str ipe; pliant; an d 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 Medical® 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 Medica l® Ventricular Cath eter with BioGli de

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 Medical® 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 Medical® 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 Medical® Translucent Ventricular Catheter

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

PS Medica l® Translucent Ventri cular Catheter w ith Radiopaqu e 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 Medica l® Slotted Ventric ular 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 Medical® 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 Medical® 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 Medica l® Snap Assembly Ven tricular Cathet er

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 i njection . 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 Medical® Pliant Ventricular Catheter

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

PS Medical® 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 i njection .

PS Medica l® Opus® Ventricular Ca theter with Opu s® Stylet

PS Medic al® Opus® Ventr icular Cathe ters provid e the physicia n with immedia te visualiza tion of CSF upo n correct 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 placeme nt (Fig 4a). The Opu s Stylet 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 4 b). The Luer-lock ou tlet grip als o allows att achment of a sy ringe for C SF sampling.

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 radiop acity. Relat ively rm tub ing is incorp orated in the c atheter des ign to provid e resistanc e to catheter k inking and compre ssion. A right a ngle clip is pa ckaged wit h each cathet er. The clip is des igned to angul ate the cathe ter at the burr-ho le site witho ut kinking. T he tip of the Op us Ventricula r Catheter is b ullet-shape d and is lled wi th radiopaq ue tantal um-impreg nated silico ne elastome r. Black length ma rkers are po sitioned on t he catheter a t 5, 10 and 15 cm from t he proximal t ip to enable the s urgeon to gaug e the depth of pe netratio n of the cathe ter into the late ral ventric le. The proxi mal end of the ca theter has 32 ow h oles-four li nes of eight ho les spaced at 9 0° interva ls around the catheter circumference.

4a 4b

PS Medica l® Rivulet® Ventricu lar Catheter

The Rivu let Ventricul ar Catheter co ntains vary ing sized and ev enly placed in let holes (Fig5), de signed to equ alize the dist ribution 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 barium-impregnated silicone elastomer tubing. The cathet ers are radio paque, and are k ink and compre ssion resis tant. They mea sure 15 cm (5.9”) in leng th, 0.15 cm (.06”) in inn er diameter, and 0.2 5 cm (.100”) in outer dia meter, and contai n black graph ite-impre gnated silico ne elastomer-length 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 drill or b urr hole (Fig6). (T he clip must b e removed when t he catheter i s used with th e Burr Hole Valve). Th e clip may

Right Angle Clip

Suture Tie

Ventricular Catheter

be used as a m arker for planned depth of catheter insertion by sliding it the appropriate distance from the proximal tip of the catheter prior to insertion (Fig7); this c an be done with the s tylet in th e

catheter. After the catheter is properly positioned in the vent ricle, the ex tracran ial portio n of the cathet er is presse d into the split t ubular segm ent of the cli p to form the rig ht angle bend (F ig8 and Fig9). Avoid str etching the c atheter wh en it is presse d into the clip. I f the cathet er is to be placed in the vent ricle throu gh a tubular in troducer, the clip mus t be removed pr ior to inser tion of the catheter through the introducer.

It is reco mmended that t he right angl e clip be secure d to adjacent ti ssue by passi ng sutures th rough the tw o suture hole s on the sides of t he clip (Fig6). If th e right angle cli p is not used, it i s recommend ed that the sur geon trim th e rim of the twi st drill or bu rr hole to prov ide a beveled notch whe re the cathe ter emerges a nd curves to l ie adjacent to th e 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.

PS Medica l® Ventricular Cath eter with BioGli de

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 hydro phobic chara cteristi cs (Fig10a). The hydro philic qualit ies 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.

tab groove

Burr hole

Bend catheter

push into

Skull

To ventricles

10a

10b

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.

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 bac k the lid from th e catheter tr ay.

2. Injec t sterile, fi ltered, isot onic saline in to the cathete r using a 30 cc syri nge and female l uer adapter.

3. Fill enti re lumen of cath eter with sal ine. Continue i njecting f luid into the c atheter unti l saline exit s the catheter, and the entire catheter becomes immersed in saline.

4. The cath eter may be gent ly removed fro m the tray aft er a minimum hydr ation perio d of two minute s.

Ventircular Catheter

Tray

Female Luer Adapter

30 cc Syringe

Sterile Isotonic Fluid

PS Medica l® Snap Assembly Ventriculostomy Catheter

NOTE: The Vent ricular Cat heter with Snap Ass embly base is av ailable separa tely or as an inte gral unit with pre-determined catheter lengths.

After t he ventricul ar catheter ha s been placed, a nd attache d to the reser voir base, the r eservoir b ase may be snapp ed together with the reservoir dome. A Snap Ass embly Tool is avail able separa tely to simplif y and expe dite the snap proc edure. Slip the “p rongs” of the tool u nder the rese rvoir base; th en, snap the do me onto the bas e (Fig12). After t he dome and base a re snapped togeth er, the reservo ir is placed in th e 6mm burr ho le or twist dr ill hole.

WARNING: VERIF Y COMPLETE SNAP ENGAGEM ENT AND DO NOT DISASSEM BLE THE RESERVOIR AND BASE ONCE THE Y ARE SNAPPED TOGETHER . THE RESERVOIR AND BAS E ARE DESIGNE D FOR “ONE-TIME ONLY” SNAP ASSEMBLY. METICULOUS CARE MUST BE TAKEN DURING A SSEMBLY TO PREVENT DA MAGE TO PLASTIC COMPONENT S. DISASSEMBLY AND RE-ASSEMBLY AND/O R DAMAGE TO THE PLAST IC COMPONENTS DURIN G ASSEMBLY CAN RE SULT IN UNWANTED DISCONNECTION OR IN LEAKAGE OF THE ASSE MBLY.

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 Catheters are available in a variety of congurations: small and stan dard sizes; op en and close d 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 Medica l® BariumImpregnated Distal Catheter

Barium I mpregnated D istal Cathe ters are fabr icated fro m relatively r m barium impregnated silicone elastomer tubing for radiopacity.

PS Medica l® Distal Catheter w ith BioGlide

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 H consta nt flow rate of 2 0 mL/hr.

PS Medical® 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 Medica l® Small Distal Cat heter

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 Medica l® Distal Catheter w ith Wall Slits

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 H

O 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 Medical® Translucent Distal Catheter

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

PS Medica l® Translucent Dista l Catheter with Ra diopaque Stri pe.

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 Medica l® Pliant Distal Cat heter

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

PS Medica l® Reduced Tip Dista l 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 Medica l® Open End Distal Ca theter

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 Medica l® Closed End Distal Ca theter

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-En d Distal Cat heter has wall sl it

0 of addit ional resist ance to flow to t he shunt syst em at a

openin gs placed 90° ap art around t he circumfe rence of the cat heter. These op enings are des igned to provi de protec tion from re trograde  ow. They are not desi gned as press ure/ow cont rol valves, bu t add slight res istance to ow. Maxim um resistan ce to ow at a const ant ow rate of 20 mL /hour is 3.5 cm H coated w ith graphite d uring manuf acture to min imize the poss ibility of sl itted sur face adhesio n during stor age.

0. The slit o penings are

Indications

PS Medic al® Distal Ca theters are d esigned as dis tal compone nts 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 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®reusable or disposable Subcutaneous Catheter Passer be used.

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.

PS Medica l®Distal Cathete r with BioGlide

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 hydro phobic chara cteristi cs (Fig14a). The hydro philic quali ties 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).

CAUTION: C ATHETER MUST BE FULLY HYDRATED PR IOR TO REMOVAL FROM TRAY, INSERTION O F STYLET, AND ALL OTHER HAN DLING OPERATIONS. HANDLING WITH OUT FULL HYDRATION COU LD DAMAGE THE CATHETER ’S HYDROG EL SURFACE.

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

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.

Hydration Method

1. Peel bac k the lid from th e catheter tr ay.

2. Injec t sterile, fi ltered, isot onic saline in to the cathete r using a 30 cc syri nge and female l uer adapter.

3. Fill enti re lumen of cath eter with sal ine. Continue i njecting f luid into the c atheter unti l saline exit s the catheter, and the entire catheter becomes immersed in saline.

4. The cath eter may be gent ly removed fro m the tray aft er a minimum hydr ation perio d of two minute s.

B-D

Tray

Sterile Isotonic Fluid

Catheter Pa tency Check

1. Inser t a 17-gauge b lunt needle in to the open, pro ximal end of the c atheter and u sh with gentle s yringe pressure using sterile physiological saline.

2. Obser ve the slit open ings near the di stal end. All op enings shoul d allow uid ow an d appear to open f or their entire length.

3. Gently r olling the slit o pening area of t he catheter b etween the t humb and fore nger will fre e the slits if they do not a ppear to open co mpletely.

4. Smooth t he catheter wa ll with the thum b and foreng er so the slit op enings are in clo sed positi on after completion of the patency test.

PS Medical® CSF-Flow Control Valves

Description

PS Medic al® CSF-ow co ntrol valves, Co ntoured, Sta ndard, Burr Hol e, Ultra Small, an d Button are diagrammed in gure s 16 through 20. These va lves are fabr icated from silicone elastomer and polypropylene. The Contoured Valves are av ailable in two models, R egular and Smal l, to accommodate dierent patient groups. The Burr Hole Valves are availa ble in two size s: 12 mm and 16 mm. The C ontoured, Standar d, and Burr Hole Val ves come in low, me dium, and high-pressure ranges. The Ultra Small and Bu tton Valves hav e an ultra -low prole fo r use in premat ure infants a nd come in low-lo w, low, and medium pressure ranges.

All valve s are marked wit h a tantalum-impregnated radiop aque arrow to indicate proximal to distal ow dire ction (with t he exception of the Burr Hole Valves), and a rad iopaque dot code t hat allows x-ray identication of the valve pressure. Radiopaque markers at the bas e of each connec tor allow the p hysician x-ray visuali zation of the r elative positi ons of cathete rs and valve in vivo when radiopaque cathet ers are used.

All valve s (with the excep tion of the But ton Valves) inclu de an injec table dome an d a polypr opylene nee dle guard. The Conto ured Valves inc lude proxima l and distal oc cluders for two -way ushing . The Ultra Sma ll Valves includ e one ushing occluder.

The valve s are available i n a variet y of sizes and pr essure ranges. Pressure/ow charac teristic s and dot codes of all the va lves are shown i n gures 21 an d 22.

Indications

The CSF- ow control va lves, Contoured, Standard, Burr Hole, Ult ra Small, and But ton, are the components of CSFow control shunts designed to provid e controlled C SF ow from th e ventricles o f the brain int o the right atr ium of the heart or the peritoneum.

Contoured

Silicone dome

Reservoir

Standard

Radiopaque

Polypropylene Base

Burr Hole

Silicone

dome

Suture

hole

Silicone

membrane

Ultra Small

Radiopaque

Button

Occluder

Marker

Outlet Ports

valve

Reservoir

Silicone Dome

Marker

Polypropylene

Outlet port

Silicone Dome

Polypropylene plastic needle

Base

Reservoir

Polypropylene

shield

30 cc SyringeFemale Luer Adapter

Peritonieal Catheter

Pressure Dots

base

Radiopaque Pressure Dots

Outlet Ports

14a

14b

Radiopaque pressure dots

Reservoir

Radiopaque marker

Integral inlet connector

Radiopaque ﬂo direction arrow

Silicone membrane valve

Radiopaque Flow Direction Arrow

Reservoir

Silicone Membrane Valve

Polypropylene base

Radiopaque Flow Direction Arrow

Occluder

Silicone Membrane Valve

Radiopaque ﬂow directon arrow

Plastic base

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 •••

High Pressure

Medium Pressure

Low Pressure

Low-Low Pressure

Flow Rate (mL/hr)

170

All valves perform within +/- 25 mm H

at time of manufacture. Low-Low Pressures are within +/- 10 mm H2O at 5 mL/hr and +/- 20 mm H2O at 50 mL/hr

105

at time of manufacture.

Every PS Medical valve is tested for its performance characteristics using a water-ﬁlled system at the time of

manufacture to assure consistent high

quality. All valves must conform to labeling speciﬁcations in these tests.

diﬀerent results depending on test

conditions and condition of the valve.

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 connec tors with en circling lig ature. Contour ed, Ultra Smal l, Standard, and B utton Valves a re placed with t he 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 Stand ard, Contoure d, Ultra Small, a nd Button Valve s are marked wi th a radiopaqu e arrow pointe d 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-t o-tissue anc horing. The Co ntoured, Sta ndard and Ultr a Small Valves may be s utured to adja cent tissue by 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.

Injec tion into the Valve

CSF-ow c ontrol valve s (other than the Bu tton Valve) are designed to allow injection through the dome via 25-gauge or smaller noncoring needles (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 AND R EMOVAL OF THE NEEDLE.

The need le should be ins erted at an ang le no greater th an 45° from the sc alp or valve bas e. If the valve wil l be punct ured several t imes, it is rec ommended tha t the needle be i nserted at v arious loca tions to avoid mul tiple punctures at a single point. The catheter tubing and occluders should not be used as injection sites.

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 Contro l Valves: Patency Chec k

Standar d (Fig 24), and Contoure d (Fig 25) Valves Pate ncy Check

a. Place th e inlet connec tor of the valv e into sterile i sotonic sali ne. b. Pump the val ve by depressi ng and releasin g the central r eservoir s ection of th e valve to ll with  uid and

displace all air.

c. D epress and re lease the valve c entral rese rvoir repea tedly until u id ows out of the o utlet conne ctor. 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.

Sterile Istotonic Fluid

10 cc Syringe (lled with sterile isotonic saline)

Outlet

Occlude distal catheter connector

Fluid Line

Outlet

16-gauge Blunt Needle Adapter

Pump Dome

Inlet

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ll v alve and tubing . c. Occlude inlet tubing. d. Depres s dome. If uid o ws out of the out let connect or, the valve is pate nt.

Burr Hole Val ve Patency Check (Fig 27)

a. Place th e inlet connec tor of the valv e into sterile i sotonic sali ne. b. Depress the valve dome. c. Place a nger over th e opening at the e nd of the outle t connector. d. Releas e the depress ed dome. If uid en ters the res ervoir, the inle t connecto r and ow contro l membrane

valve are patent.* e. Remove nger from the outlet connector opening. f. Depres s dome. If uid ow s out of the outl et connect or, the valve is pate nt. * * NOTE: It m ay be necessar y to depress t he valve dome mo re than once to ini tiate ow, espec ially if the

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

Button Va lve Patency Check (Fig 28)

a. Att ach a 16-gauge b lunt needle an d

b. Flush t he valve with s terile isot onic saline. c. If uid ows out of t he distal con nector,

Compress valve dome

Sterile Isotonic Fluid

syringe to the valve inlet.

the valve i s patent.

Preimplantation Test

Each CSF -ow control v alve is tested t o ensure conformance with its labeled performance characteristics. Although verication of a valve’s dynamic performance characteristics using a st atic test tha t can be perf ormed in the operat ing room is not po ssible, the su rgeon may wish to verify that the valve conforms to Medtronic Neurosurgery’s specications prior to implantation. The followi ng preimplan tation test m ay be perfor med in the oper ating room:

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

Test Method I. Equipment required for test

1. Steril e uid reser voir or steril e water bath

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

3. One thr ee-way stop cock (to be used w ith manomete r)

4. One ste rile syrin ge, 30 cc

5. One ste rile 5 µ syrin ge lter

25-gauge needle or smaller

Outlet

Pump Dome

Inlet

Release valve dome

Depress dome

Fluid Line

Sterile Isotonic Fluid

Inlet

10 cc Syringe (lled with sterile isotonic saline)

Occlude Tubing

Outlet

16-gauge Blunt Needle Adapter

Pump Dome

Outlet

6. One ste rile male Luer c onnector

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. Fill sy ringe with s terile water us ing 5 µ syringe  lter. (When rel ling syring e, always use 5 µ sy ringe lter.) After lling syringe, detach syringe lter.

cap (detached)

Syringe ﬁlter (detached)

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

4. To purge a ll air from th e assembled s terile tes t appa ratus t urn st opcoc k as show n in Fig ure 30a .

5. Submerg e silicone tub ing in the ster ile water bath an d ush with ste rile water fr om syringe.

III. Equipment calibration

1. Turn stop cock as shown in F igure 30b and ll man ometer to at leas t 5 cm H

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

3. Allow wa ter column in the m anometer to fall.

4. Water colu mn should sto p at zero level of the manometer, as shown in gure29. If n ot, raise or lowe r manometer accordingly.

5. Manome ter is now calibr ated 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. Connec t the steri le valve to be tes ted to the asse mbled steri le test appar atus.

2. Turn stop cock as shown in  gure30b and ll man ometer to at leas t 30 cm H

3. Turn stop cock to isolat e manometer from ow p ath as shown in g ure30a.

4. Purge al l air from the va lve and the assemb led test appa ratus by gentl y ushing w ith sterile w ater from syringe.

5. Gentl y establish  ow through the v alve with ste rile water fr om the syrin ge.

6. Submer ge sterile va lve in the steri le 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. While ge ntly maintai ning ow throu gh the valve, tur n stopcock to i solate syri nge from ow pa th 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.

30 cm

Silicone tubing

Correct manometer alignment

30a

From syringe

30b

30c

1/4

From syringe

Oﬀ

-3

F F

Oﬀ

-3

To manometer

-3

From manometer

To valve

Constant lev water bath

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 H

Low ........................................................................................ 1–50 mm H

Medium ............................................................................. 50–110 mm H

High ..................................................................................110–170 mm H

PS Medical® CSF-Ventriculostomy Reservoirs

Description

CSF-ventriculostomy reservoirs are designed to provide percutaneous access to the ventricular cerebrospinal uid (CSF). Any PS Me dical®CSF- ventriculo stomy reser voir can be us ed independ ently as a reser voir or as a comp onent 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 percut aneous inje ction. The b ase is made with a n integral ca theter conne ctor design ed to facilit ate implanta tion 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 Me dical®CSF- ow control va lve may be direc tly connec ted to the res ervoirs.

Ventriculostomy Reservoir

The Pull-Over Ventriculostomy Reser voir (Fig31) is availabl e in 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).

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 reservoirs, or as components of 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 be g auged befor e insertio n and trimmed . After trimm ing, the cath eter may be xed to t he reservoi r base by an enci rcling ligatu re (non-uniti zed version s only). The cathet er and base may then be pl aced as an assem bly using a sta inless steel s tylet. Af ter cathete r placement, t he silicone ela stomer cap is tte d over the reser voir base, an d the assemble d CSF-ventr iculostomy r eservoir is p laced in the bur r hole or twis t drill 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 injec tion through t he reservo ir dome, and if de sired, allow fo r the possibl e addition of a C SF-ow contro l 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.

Radiopaque Silicone Dome

Plastic Base

Plastic Straight Connector

Plastic Tubing Plug

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 Me dical®CSF- shunt by sutur ing the connec tor to the inle t tubing of the sh unt. A PS Medic al®CSF-ow co ntrol valve or s hunt with 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

3534

Straight connector

Injec tion into the Rese rvoir

The CSF-ventriculostomy reservoir is designed to allow injection through the dome by use of a 25-gauge or smaller noncoring 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 ventricul ar catheter ha s been placed, a nd attache d to the reser voir base, the re servoir ba se may be

snappe d together wit h the reser voir dome. A Snap A ssembly Tool is av ailable separ ately to simpl ify and exp edite the snap pr ocedure. Slip t he “prongs” of t he tool under th e reservoi r base; then, sna p the dome onto th e base (See Figure 12). Aft er the dome and ba se are snappe d together, the re servoir is p laced in the 6 mm bur r hole or twis t drill hole.

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 A SSEMBLY 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, conne ction, and p lacement of the v alve or shunt, it m ust be fully hy drated with s terile, lter ed, isotonic saline. Full hydration is accomplished in a minimum of two minutes. Each PS Medical®valve and shunt with Bio Glide is pack aged in a tray, with in a well, which acc ommodates th e hydrating so lution.

NOTE: If present, the Delta® 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 of t he 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 bac k the Tyvek lid fro m the valve hydra tion tray.

2. Attac h a 60 cc syring e to the blunt nee dle include d in the tray and ll t he syringe w ith saline.

3. Inser t blunt need le and syring e into prell ada pter.

4. Attac h syringe an d adapter assem bly to the Snap Re servoir Ba se.

5. Fill e ntire shunt wi th uid. Cont inue injec ting uid unt il saline exi ts the dist al catheter, and t he entire shu nt is immersed in saline.

6. The syr inge may have to be re lled to ll the e ntire tray well .

7. Ensure t hat the shunt is co mpletely sub merged for a f ull two minute s.

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. At tach the tr anslucent pr ell adapter t o the inlet of the r eservoi r dome.

2. Using the 16 -gauge blunt n eedle adapte r, ll a syringe wi th sterile, l tered, isoton ic saline.

3. Inser t the blunt nee dle adapter into t he port of th e prell adapte r, and using gentle s yringe pre ssure, ush shun t assembly wi th the saline.

4. If the sa line ows out of t he distal ca theter end, th e shunt assemb ly is patent. NOTE: Pressure/ow test instructions are available upon request from the Medtronic Neurosurgery Customer Service department.

PS Medical® CSF-Shunt Assemblies and Shunt Assembly Kits

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 a nd 22.

A variety 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 pertai n to the individ ual valve. Altho ugh 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 H distal c atheters a nd 3.5 cm H

O 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 surgica l techniques m ay be used in plac ing the CSF-Shun t Assemblie s. Shunt size and p ressure ran ge are at the di scretion of t he surgeon. T he valve is place d with the at sur face adjace nt to the peric ranium. The va lve may be sec ured to adjacen t tissue by sutu ring throug h its fabric-rei nforced ang e (Contoured, St andard, Ultra Small, and B urr 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® Shu nt Assembly with BioGl ide (Fig 36)

NOTE: If present, the Delta® 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 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 of t he 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

is packa ged in a tray, withi n a well, which acc ommodates th e hydrating sol ution.

1. Peel bac k the Tyvek lid fro m the valve hydra tion tray.

O for open -end

valve and s hunt

Tubing

2. Attac h a 60 cc syringe t o the luer-lock c onnector an d ll shunt.

Flow Rate (mL/hr)

Pressure (mm H

performance characteristics using a water-ﬁlled

push into tab groove

VentricleSkull

Flow hole

Right angle clip

Elastic silicone tube

Stainless steel stylet

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. Ensure th at the shunt ass embly with Bi oGlide is comp letely subme rged for a full t wo minutes.

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 ventr icular 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 dome o f the Standard, Co ntoured, Ult ra Small, and Bur r Hole Valves is de signed to allow i njection v ia a 25-gau ge or smaller no ncoring need le (Fig23). The rm po lypropylen e base is design ed to help preve nt complete penetration of the valve.

CAUTION: TH E BUTTON VALVE IS NOT DESIGN ED TO ALLOW INJECTION W ITH 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®reusable or disposable Subcutaneous Catheter Passer be used.

The Disp osable Cath eter Passer is de signed to be di rected dis tally throu gh the subcut aneous space w ith the handle an d obturator in p lace. The tubul ar passer shaf t is malleabl e and may be hand fo rmed by the surg eon. After p lacement of the p asser, the obtur ator is unloc ked from the han dle and the hand le is removed fr om the passer s haft. The di stal end of the p eritoneal c atheter is the n placed on the ob turator end t ting. Obtu rator and cath eter are then dr awn through th e passer shaf t by pulling th e distal obtu rator tip. The o bturator is th en removed f rom the cath eter tubing. T he passer shaf t can now be wi thdrawn cau dally through t he 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.

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, an d Burr Hole Valves) (Figs 24 , 25, and 27)

a. Place inlet connector of valve into sterile isotonic saline. b. Depr ess and relea se the valve dom e repeatedl y until uid ow s out of the dis tal cathet er. Observe th e 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 rollin g the slit openin g area betwe en the thumb and f orenger wi ll free slit s if they do not app ear

to open completely.

d. Smooth c atheter wall w ith thumb and f orenger so sl it openings ar e in the closed p osition af ter

completion of the patency check.

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

a. Using a 16- gauge blunt n eedle adapter, l l a syringe wit h sterile, lt ered, isotoni c saline. b. Inser t blunt needl e into the tubing a ttached to t he proximal en d of the valve. Usin g gentle syr inge

pressu re, ush shunt wi th saline.

c. I f saline ows ou t of the distal c atheter end, t he shunt is pate nt.

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ll v alve and tubing . c. Occlude inlet tubing. d. Depres s dome. If uid o ws out of the prox imal cathet er, the valve is paten t.

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.

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

Design & Manufacturing Facility:

Medtronic Neurosurgery

125 Cremona Drive Goleta, California 93117 USA (800) 468-9710 USA/Canada (800) 468-9713 FAX USA/Canada

X401-1H

2016 - 03

PS Medical® Snap Shunt Assemblies

Description

PS Medic al® Snap Shunt As semblies ar e comprised o f several comp onents: a But ton Valve (Fig20) or U ltra Small Valve (Fig19), an inte gral Snap Ass embly Ventric ulostomy Res ervoir Dome , and an integra l Peritoneal Ca theter. 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.

120

100

5203040

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 H 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 ventricle s for injec tion, sampl ing and drain age. The integ ral Periton eal Catheter, Op en End with Wall Sl its, minimi zes potentia l catheter oc clusion. Ea ch shunt valve is individually tested to ensure conformance with its labeled pressure/flow characteristics.

O. The slit op enings are coa ted with grap hite during ma nufactur e to minimize the

Medium Pressure

Low Pressure

Low-Low Pressure

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 H +/- 20 mm H

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 speciﬁcations in these tests. Subsequent testing of the valve may give diﬀerent results depending on test conditions

and condition of the valve.

O at 5 mL/hr and

O at 50 mL/hr .

PS Medica l® Snap Shunt Ventri cular Catheter (ava ilable sepa rately, see cathete r section)

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

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 used w ith 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 locati ons to avoid repe ated punct ures at a single p oint on the dome i s recommende d. Product p erforman ce 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 H 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 Valve

CAUTION: TH E BUTTON VALVE DOES NOT INCLU DE AN INJECTABLE CENTR AL RESERVOIR.

The need le should be ins erted at an ang le no greater th an 45° from the sc alp or base of th e valve. If the val ve 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 injec tion 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 depre ssion of the Ult ra Small Valve dom e will force CSF o ut of the valve in b oth proximal a nd distal direc tions. To selec tively fl ush, depress an d occlude eit her the proxim al tubing or val ve occluder by pe rcutaneou s finge r pressure, th en depress th e valve dome. This w ill cause f luid to flow in t he directi on opposite th e occluded side of the v alve. If there is n oticeable re sistance to do me compressi on, the cathe ter to be flush ed may be occluded.

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 subcutaneous catheter passer is available for tunneling of the distal catheter. The PS Medical®Subcutaneous Cathet er Passer, 38 or 60 cm i n length, is rec ommended.

Shunt Pate ncy Check

1. Attac h the transluce nt prefill adapter t o the inlet of the reser voir dome (Fig4 0).

2. Using the 16-gauge blunt needle adapter, fill a syringe with sterile, filtered, isotonic saline.

3. Inser t the blunt nee dle adapter into the po rt of the pre fill adapter, and u sing gentle syrin ge pressure, f lush shunt assembly with the saline.

4. If the sal ine flows ou t of the distal c atheter end, t he shunt assembly is patent.

NOTE: Pressure/ow test instructions are availa ble upon requ est from the Medtronic Neurosurgery Customer Service department.

16-gauge Blunt Needle Adapter

30 cc Syringe

Reservoir Dome

Prell

Adapter

Button Valve

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 (Contoure d, Standard, an d Burr Hole Valve s). A radiopaque do t code on the valve i ndicates va lve pressure. Pressu re/ow chara cteristi cs are shown in  gures 21 and 22.

A variet y of PS Medica l® 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 gur e 22 pertai n to the individ ual valve. Altho ugh 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 H distal c atheters a nd 3.5 cm H

O 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 s ized valve is ind icated.

O for open -end

Instructions for Use

Surgical Technique

A variety of surgical techniques may be used in placing the CSF-Unitized Shunts. The intracranial ventricular catheter length and peritoneal catheter length are at the discretion of the surgeon. The Contoured, Ultra Small, Butto n, and Standard Val ves are placed w ith the at sur face adjacen t to the pericr anium. The Bur r Hole Valve is design ed to t into a form al burr hole. Th e upper surf aces of the Stan dard, Contour ed, Button, a nd Ultra Small Valves are m arked with a rad iopaque arr ow pointed dis tally (in the di rection of C SF ow). Suture hol es are provided on the Burr Hole Valve anges to accommodate valve-to-tissue anchoring. The Contoured, Standard, and Ultra Sma ll Valves may be sut ured to adjacen t tissue by pass ing a suture thr ough the fab ric-reinforce d 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.

PS Medical® Catheter Connectors

Description

PS Medica l® Catheter Connec tor, Straight

The Cath eter Connec tor, Straight (Fig5 0a), is a nylon or stai nless steel c onnector d esigned for u se with PS Medical®ventricular and distal catheters.

PS Medica l® Catheter Connec tor, Right Angle

The Catheter Connector, Right Angle (Fig50b), is a nylon connector designed for use with PS Medical®ventricular catheters.

PS Medica l® Catheter Connec tor, 3-Way

The Catheter Connector, 3-Way (Fig50c), is a polypropylene and silicone elastomer connector designed to connect two PS Medical®ventricular catheters to one PS Medical®CSF-ow control valve inlet connector.

50a 50b 50c

Ventricular Catheter Placement

A disposable quick-release ventricular catheter introducer is supplied with each unitized shunt (Fig41). The introducer tip is designed for insertion into the ventricular catheter via the ow h ole closes t to the valve (Fig42).

The tip is i nserted in to the cathet er ow hole; the n, catheter and introducer are held rmly together and inserted into the ventricle. When the desired catheter locati on is achieve d, the shaft gr ip is held rm ly as the st ylet grip is pu lled back app roximately 1.5 c m, releasi ng the cathe ter from the in troducer (Fi g43). The intr oducer may now be w

thdraw n from the vent ricle.

The right angle clip on the ventric ular cathe ter may be used to bend th e ventricula r catheter to an approx imate 90˚ angl e where it exit s the twist d rill or burr h ole (Fig 44). The c lip may be used a s a marker fo r planned dep th of catheter insertion by sliding it the desire d distance f rom the proxi mal tip of the c atheter pri or to inser tion (Fig45 ). If the su rgeon does n ot wish to use t he clip it may be e asily removed prior to insertion of the ventricular catheter.

After t he catheter i s located pro perly in the ventricle, the extracranial portion 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 st retching th e cathet er when it is pre ssed into the c lip. It is recommended that the right angle clip be secu red to adjacen t tissue by pass ing sutures through the two suture anges on the side s of the clip (Fig4 4).

If the rig ht angle clip is no t used with the Uniti zed Shunt, it is r ecommende d that the su rgeon trim t he rim of the bur r hole to pro vide a beveled n otch where the cath eter emerge s and curves to l ie adjacent to th e skull. A subgal eal pocket m ust be forme d with approp riate depth to a ccept the ext racranial portion of the ventricular catheter and the valve.

Injec tion into the Valve

The dome on the Standard, Contoured, Ultra Small, and B urr Hole Valves is d esigned to all ow injec tion via a 25-g auge or smaller n oncoring needle (F ig23, see valve se ction). The rm polypr opylene bas e is designed to h elp prevent complete penetration of the valve.

CAUTION: TH E BUTTON VALVE IS NOT DESIGNED TO A LLOW INJECTION WITH A NEEDLE. A SEPAR ATE RESERVOIR OR ANTECHAMBE R IS REQUIRED FOR CSF ACCESS.

The need le should be ins erted at an ang le no greater t han 45˚ from the s calp or base of t he valve. If th e valve will be pu nctured se veral times, inserting the needle at various locations is recom mended in orde r to avoid repeat ed

punct ures at a single p oint on the dome . The catheter t ubing and occ luder are not to be u sed as injec tion sites.

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 cl osed tip. The c losed-end c atheter 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 end is not recom mended for c ardiac placem ent.

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Medic al®reusabl e or disposab le Subcutan eous Cathet er Passer be use d.

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.

CSF-Flow Contro l Valve Pressure/Flo w Test

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, testin g at multiple d ata points, t ime to conduc t the test ing, and care ful atten tion 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 Pate ncy Check (Con toured, Stand ard, and Burr H ole Valves)

Prior to implantation, the surgeon may utilize the foll owing test to ve rify pate ncy of the shu nt:

Place the inlet holes of Ventricular Catheter i

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

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

CAUTION: PARTICULATE MATTER IN THE TEST SOLUTION M AY AFFECT TEST RESULTS AND PROD UCT PERFORMANCE.

CAUTION: E XCESSIVE FLUSHING PRE SSURE MAY CAUSE TEMPORA RY DEFORMATION OF THE VALVE MEM BRANE AND RESULT IN ABNOR MALLY LOW PRESSURE/FLOW PERFORMANCE.

Shunt Pate ncy Check (Butto n Valve Fig 48)

a. Atta ch 18-gauge blu nt needle adap ter to syring e

and inser t blunt nee dle into most di stal ow hole of the ventricular catheter.

b. Using gen tle syringe p ressure, us h shunt with

sterile isotonic fluid.

c. I f saline ows ou t of the distal c atheter end, t he

shunt is patent.

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

a. Atta ch 18-gauge blu nt needle adap ter to syring e

and inser t blunt nee dle into most di stal ow hole

of the ventricular catheter. b. Prell shunt. c. Occlude ventricular catheter. d. Depres s dome. If uid ow s out of the inte gral

peritoneal catheter, the valve is patent.

Stylet grip

the

Peritoneal Catheter, the shunt is patent.

Twist drill or

burr hole

Right angle

Ventricular

catheter

CSF-ﬂow control valve, contoured

Bend catheter;

Depress Valve Dome

Stainless steel shaft

clip

Fluid Line

shaft grip

Catheter

Suture

Sterile Isotonic Fluid

10 cc Syringe (lled with sterile isotonic saline)

30 cc Syringe (lled with sterile

isotonic saline solution)

Ventricular Catheter

Button Valve

18-gauge Blunt Needle Adapter

Indications

PS Medica l® Catheter Connec tor, Straight

The Cath eter Connec tor, Straight, is i ndicated fo r use when dist al or ventricu lar catheter r evision is re quired, or to connec t a ventricul ar catheter to t he inlet por t of a PS Medical ®valve.

PS Medica l® Catheter Connec tor, Right Angle

The Cath eter Connec tor, Right Angle, is i ndicated fo r use to angulate t he ventricu lar catheter to a 9 0° angle (nominal) w here it exit s the twist dr ill or burr hol e.

PS Medica l® Catheter Connec tor, 3-Way

The Cath eter Connec tor, 3-Way, is indicate d for use when t wo PS Medical® ventricul ar catheter s are connect ed to one PS Medical®CSF-Flow Control valve.

Instructions for Use

The surgical technique employed in the use of catheter connectors is at the discretion of the surgeon.

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

Description

PS Medical® disposable subcutaneous catheter passers are disposable surgical instrume nts. They are available in two leng ths, 38 cm and 60 c m, and consist o f two compone nts:

1. A tubular s haft with p olypropyle ne T-shaped hand le.

2. An obtur ator with bull et-shaped tip. The instruments are designed as malleable subcutaneous tunneling devices for passing cerebrospinal uid shunt cathet ers (Fig 51).

Catheter connection

Polypropylene handle

Stainless steel shaft

Polypropylene obturator tip

Indications

The PS Med ical®dispos able subcut aneous cath eter passer s are used for t he placement of t he peritone al catheter 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 Disp osable Subc utaneous Ca theter Passe rs is at the disc retion of the sur geon. The surg eon is advise d to ensure that t he catheter wi ll pass throu gh the instru ment prior to beginn ing the proced ure. The tubul ar shaft is mal leable and may be ha nd-forme d by the surgeon a s indicated f or the oper ative proced ures. When th e instrumen t is passed sub cutaneous ly, the obturato r must be inser ted in the tubular s haft and sec ured in the han dle by snapping t he obturator ’s locking tip i nto position . After remov al of the handle an d obturator, the c atheter may be h and-fed thro ugh the lumen of t he tubular sha ft.

The obtu rator also inc ludes a cathe ter attachm ent site for at tachment of a n open ended dis tal cathet er. Attac hment of the cat heter to the obt urator allow s catheters o f appropria te I.D. (inner diame ter) to be pulled through the passer shaft.

PS Medical® Products

How Supplied

PS Medic al®CSF-ow co ntrol produ cts are pac kaged STERILE and NON-PY ROGENIC. 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 tructio ns for use accom panies a spec ial order pro duct, there m ay be dierenc es in the physic al characteristics between the product and product descr iption in this product package insert. These dierences will not a ect the saf ety or eca cy of the spec ial order pro duct. Speci al order prod ucts may be sup plied sterile or non-sterile as indic ated on the prod uct packag e label. Non-s terile pro ducts mus t be cleane d and

steri lized prior t o use.

Contraindications

Shuntin g of CSF into the ri ght atrium, pe ritoneal cav ity, or other ar eas of the body s hould not be car ried out if there is in fection i n any areas in whic h the various co mponents of t he shunt syst em will be impla nted. These include i nfectio ns of the scalp an d other skin are a through whic h the shunt sys tem will trave rse, the menin ges and cerebral ventricles, peritoneum and intraperitoneal and retroperitoneal organs, pleura and blood stream. CSF shunt ing is contrai ndicated if t here is infec tion prese nt in any area of the b ody. Addition ally, shunting into the atrium of patients with congenital heart disease or other serious cardiopulmonary abnormalities is contraindicated.

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 secur ing the ventr icular and dis tal cathete rs to the valve co nnectors , the ligature s encircling t he tube should b e 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.

Shunt obs tructio n may occur in any of t he component s of the shunt sy stem. The vent ricular cat heter may beco me occlud ed by partic ulate matter su ch as blood clo ts or brain fr agments, by in vestment of t he catheter ti p in choroid plexus , by embedding o f the cathete r in brain tissu e, or by coaptati on of the ventr icular walls in t he presence of overdrainage (“slit ventricles”).

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 imbalance and e xcessive blo od loss, par ticularly in i nfants. 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 proced ures. Usuall y, they are due to org anisms inhab iting the ski n, particu larly Staphylococcus epidermidis. Other pathog ens circulat ing in the blo od stream may co lonize the shu nt and, in the maj ority of pa tients, req uire its rem oval.

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. reporte d signican t reductio ns in infect ion (less than 4%) wi th the use of anti biotics, sh ort duration of surgery (surgical experience) and control of the operating room environment (e.g., designated operat ing room, limi ted personn el and trac, co vered skin sur faces). The ar ticle state s that result s can also be obtained 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 pressu re and predis pose the devel opment 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. In the infant , this excessi ve pressure reduction will cause marked depression of the anterior fontanelle, overriding of cranial bones and may convert communicating into obstructive hydrocephalus.

The inci dence of epilep sy after ven tricular shu nting proced ures has been r eported. T his study als o indicated th at the incidence of seizures increased with multiple catheter revisions.

Returned Goods Policy

Produc ts must be re turned in uno pened packa ges, with manu facture r’s seals intac t, to be accepte d for replace ment or credi t, unless ret urned due to a com plaint of prod uct defec t or mislabeli ng. Determin ation of a produc t defect o r mislabeling w ill be made by Med tronic Neuro surgery, whi ch determina tion will be na l. Produc ts will not be a ccepted for re placement or cr edit if they ha ve been in the pos session of th e customer fo r more than 9 0 days.

Warra nty

A. Stand ard Limited Wa rranty. Medtronic Neurosurgery warrants to the original end user purchaser

(“Purcha ser”) tha t the enclosed s ingle use impl antable pro duct (“Prod uct”) pu rchased by Pur chaser, at the time of de livery to Purc haser, shall be sub stantiall y free from de fects in ma terial and wor kmanship. Med tronic Neurosu rgery make s no warranty (e xpress, imp lied, or statu tory) for Pro ducts that a re modied (exc ept as expre ssly contempl ated herein) or su bjected to un usual physic al stress, mi suse, imprope r operation, n eglect, improp er testing, us e in combinati on with other p roducts o r components o ther than thos e for which th e Products were desi gned, or use in an y manner or medi cal procedu re for which th e Products a re not indicat ed.

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 other wise desig nated by Medt ronic Neuros urgery; and (i ii) Medtroni c 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

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 Medica l® Barium-Impregnated Ventricular Catheter PS Medica l® Ventricular Cathe ter with BioGli de PS Medica l® Standard Ventricular Catheters PS Medica l® Small Ventricular Catheters PS Medica l® Translucent Ventricular Catheter PS Medica l® Translucent Ventri cular Catheter w ith Radiopaqu e Stripe PS Medica l® Slotted Ventricular Catheter PS Medica l® Innervision Ventricular Catheter PS Medica l® Flanged Ventricular Catheter PS Medica l® Snap Assembly Ven tricular Cathet er PS Medica l® Pliant Ventricular Catheter PS Medica l® Ventriculostomy Ventricular Catheter PS Medica l® Opus® Ventricular Ca theter with Opu s® Stylet

PS Medical® Distal Catheters

PS Medica l® Barium-Impregnated Distal Catheter PS Medica l® Peritoneal Cathe ter with BioGli de PS Medica l® Small Distal Catheter PS Medica l® Distal Catheter w ith Wall Slits PS Medica l® Translucent Distal Catheter PS Medica l® Pliant Distal Catheter PS Medica l® Reduced Tip Dista l Catheter PS Medica l® Open End Distal Ca theter PS Medica l® Closed End Distal Ca theter

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

PS Medical® Ventriculostomy Reservoir PS Medical® Unitized Ventriculostomy Reservoir PS Medica l® Snap Assembly Ven triculostomy Re servoir

PS Medical® CSF-Shunt Assemblies & Shunt Assembly Kits

PS Medica l® Shunt Assembly wi th BioGlide

PS Medical® Snap Shunt Assembly

PS Medica l® Snap Shunt Assem bly with BioGlid e

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

PS Medica l® Catheter Connector, Straight PS Medica l® Catheter Connec tor, Right Angle PS Medica l® Catheter Connector, 3-Way

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

Instructions for Use

Medtronic 276081 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual