Medtronic 46156 Instructions for Use

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125 Cremona Drive

Medtronic Neurosurgery

Design & Manufacturing Facility:

Minneapolis, MN 55432-5604 USA
710 Medtroni c Parkway NE
Medtronic, Inc.

Consult Instructions For Use.

Use by

Sterilization: Ethylene-Oxide Gas

Do Not Reuse

Package Contents

Reference Number

Lot Number

2017 - 10
139 60 -1J

©Medtronic, Inc. 2017

Ventriculostomy Kit

Manufacturer

Sterilize

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

Do not use if the package is damaged.

Do not resterilize.

Instructions for Use

Ventriculostomy Kit

Description

Medtro nic Neurosur gery’s Ventr iculostomy K it consists o f a complete se t of instrume nts and access ories used
during a t ypical vent riculosto my procedur e to gain access to t he ventricula r system. The c ompletenes s of the kit
saves tim e and eliminate s having to gathe r supplies; th is convenience c an be critic al in an emergen cy situatio n for
monitoring and drainage as needed.

Two kits are o ffered, t he Standard, REF 4 6156, and the Europe an, REF 46154. The Euro pean kit doe s not include
lidocaine with epinephrine or povidone-iodine (PVP scrub, solution, or ointment).

NOTE: This kit is to be used with Medtronic Neurosurgery’s EDM Ventricular Catheters.
NOTE: P VP scrub, PVP o intment, PV P solution, a nd lidocai ne with epin ephrine ar e not include d in

Europe an kit, REF 46154.

Medtronic Neurosurgery’s Standard Ventriculostomy Kit contains the following items for use with Medtronic
Neurosurgery’s EDM Ventricular Catheters, available separately.

• Ra zors (2)

• Skin preparation supplies

• Mar king pen and ru ler

• Dr ape and towels

• Ins truments f or soft tis sue dissec tion

• Han d drill

• Dr ill bits, 5/32” an d 1/4”

• Test t ubes (3)

• Sut ure material

• Wound dressings

• Instructions for Use

• Tegaderm

Indications

Use of Med tronic Neuro surgery ’s Ventriculost omy Kit is indic ated when acce ss to the lateral c erebral vent ricles
is neces sary. The Ventr iculostomy K it is intended t o be used in conju nction wit h Medtronic N eurosurger y’s EDM
Ventricular Catheters and External Drainage and Monitoring produc ts.

Contraindications

Use of the Ven triculost omy Kit, and int racranial pr essure moni toring with a ve ntricular c atheter, is
contrai ndicated in p atients rec eiving antic oagulants or w ho are known to hav e a bleeding dia thesis. The
ventric ular cathet er is contrain dicated if sc alp infect ion is presen t. A patient und ergoing ex ternal drain age and
monitor ing must be kep t under contin uous, close su pervisio n. The use of a vent ricular cath eter is contra indicated
where trained personnel are not available to supervise monitoring and drainage on a 24-hour-a-day basis.

Warnings and Precautions

It is the re sponsibilit y of the physic ian to descri be and explai n the followin g warnings, pr ecautions a nd
complications to the patient and/or their representatives prior to proceeding with any surgical procedures.

The Ventri culostomy K it drill (with dr ill bits, adj ustable chu ck, and adjus table stop) mus t be used prop erly in order
to preven t drilling too de eply and caus ing injury or d amage to the dur a, cortex, an d cortical v essels.

Failure to ap propriatel y adjust the ra te of CSF outf low through t he externa l drainage sy stem may result i n
potentially serious injury to the patient.

Lint, f ingerprin ts, talc and oth er surface c ontaminant s or residues f rom latex glov es can cause fo reign body or
allergic reactions.

Do not reu se, reproces s, or resteril ize the produc t. Reuse, rep rocessing, o r resterili zation may com promise
struc tural integ irty of th e device and/or cr eate a risk of cont amination of t he device, whic h could result i n patient
injur y, illness, or deat h. Medtronic N eurosurge ry is not respo nsible for th e performa nce of the prod uct that has

been resterilized.

Instructions for Use

The following instructions are only meant to provide general guidelines. The physician may alter the procedure
in accordance with clinical experience and medical judgment. Medtronic Neurosurgery’s Ventriculostomy Kit
is design ed to be used in co njunction w ith Medtro nic Neurosur gery’s EDM Ventr icular Cathe ters and Ex ternal
Drainage and Monitoring products.

NOTE: If using Medtronic Neurosurgery’s Drainage and Monitoring product, allow time for system
setup prior to beginning surgical procedure. Refer to the system’s Instructions for Use.

Surgical Procedure
NOTE: P VP scrub, PVP o intment, PV P solution, a nd lidocai ne with epin ephrine ar e not include d in

Europe an kit, Ref. 46154.

1. In accord ance with physi cian orders , shave the appro priate area of th e head. The pre frontal are a, off the
midline, i s suggested , since it allows f ree movement o f the head and is co smetically a cceptable (be hind
the hair line). The side is det ermined by int racranial in jury or abno rmality, cere bral dominanc e, and the
presen ce or absence of s calp lacerat ion.

2. Prep the sk in with PVP sc rub and paint wi th PVP soluti on.

3. Mark the i ncision site s with the ster ile marking pe n. Infiltr ate both incis ion sites and th e tunnel path wi th
lidocaine with epinephrine.

4. Apply st erile drape s.

5. Make a linea r incision 2-3 cm in le ngth just ante rior to the cor onal suture wi th the #15 blade, and ca rry
down to the s kull.

6. Place the self-retaining retractor.

7. Inser t the appropr iate-sized d rill bit into th e drill chuck . Hold the drill h andle motion less and rotat e the
chuck to t ighten it again st the drill bi t.

8. The hand dr ill bit can eas ily be set to a leng th determin ed to be equal to sk ull thicknes s. To set the depth,
positi on the adjust able stop over th e drill bit. Wh en the appropr iate drill bit l ength has bee n reached,
secure t he adjustab le stop by turn ing the set scr ew clockw ise with the he x wrench.

WARNING: THE SMA LL SET SCREW MUST BE ADEQUATELY TIGH TENED ON THE ADJUSTABLE STO P.

9. Drill a ho le through the o uter and inner t ables of the sku ll. Exercis e caution to pre vent inadver tent
damage or i njury to the du ra, cortex , and cortic al vessels.

10. Make the d ural incisio n under direc t vision usin g the #11 blade.

11. Pass th e EDM Ventricular C atheter, with s tylet in pla ce, through the p arenchyma to t he lateral vent ricle
of choice . After enter ing the ventri cle, withdraw t he stylet a nd occlude the c atheter at sc alp level by
pinchin g, or with an app ropriate cla mp. Only a minimal a mount of CSF sho uld be permit ted to esca pe,
especially if ICP is elevated.

NOTE: Refer to EDM Ventricular Catheters Instructions for Use for catheter handling technique.

12. CSF may b e collected i nto the test tu bes provide d for lab analysi s, in accordance w ith physicia n’s orders.
However, los s of CSF should be m inimized.

13. The cat heter may then b e tunneled away f rom the orig inal incision .

14. Place th e connector o n the end of the EDM Ven tricular Ca theter, and ancho r in place with a ti e of the
surgeo n’s choice. Connec t the cathe ter to an Exter nal Drainag e and Monitori ng product i n accordance
with it s Instruct ions for Use.

15. Remove t he self-ret aining retra ctor, paying me ticulous at tention to hem ostasis.

16. Close t he wound in a sing le layer using 4- 0 nylon. Secu re the cathe ter in place with 4 -0 nylon and /or a
fixat ion collar or con nector, as des ired. A fixa tion collar is su pplied with t he EDM Ventricul ar Catheter, 35
cm. Use blu nt suture sci ssors to tri m suture mater ial.

17. Apply P VP ointment to t he wound and exi t site of the cat heter. Last, ap ply sterile d ressings.

18. When f inished, dis pose of Kit com ponents in an ap propriate ma nner.

How Supplied

The conte nts INSIDE the ventr iculustomy K it TRAY are su pplied STERILE in a do uble CSR-wra pped, single b arrier
packag e with the excep tion of the cont ents inside t he PVP ointmen t, solution pa ckaging, and P VP Scrub, whic h
are consi dered non-s terile. Refe r to applicabl e labeling for a ny other conten ts OUTSIDE the TRAY. The k it is
intende d for single
has been p reviously op ened or damage d.

(one-time) use only. After use, t he Kit should b e disposed of p roperly. Do not u se if package

Patient Education

It is the phy sician’s respo nsibility to e ducate the pa tient and/or the ir represen tative(s) regar ding exter nal
drainage and monitoring. This should include a description of associated complications, and an explanation of
potential alternative products and treatments.

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.

Determ ination of a pro duct defe ct or mislabe ling will be made b y Medtronic N eurosurger y, which deter mination
will be f inal.

Produc ts will not be a ccepted for re placement or cr edit if they ha ve been in posse ssion of the cu stomer for mo re
than 90 days.

Warranty

A. Standard Limited Warranty. Medtronic Neurosurgery warrants to the original end user purchaser

(“Purcha ser”) tha t the enclosed s ingle use pro duct (“Prod uct”) pu rchased by Pur chaser, at the tim e of delivery t o
Purchas er, shall be subst antially fr ee from defe cts in mater ial and workma nship. Medtr onic Neurosu rgery makes
no warra nty (expres s, implied or st atutory) fo r Product s that are modif ied (except as e xpressly co ntemplated
herein) or su bjected to u nusual physic al stress, mi suse, improp er operation , neglect, i mproper tes ting, use in
combina tion with oth er product s or component s other than th ose for which t he Product s were designe d, or use in
any manner o r medical pro cedure for wh ich the Produ cts are not in dicated.

B. Re medy. Pur chaser’s exc lusive remed y and Medtron ic Neurosurg ery’s sole lia bility for b reach of the for egoing
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
notif ied in writi ng within nine ty (90) days aft er Purchaser ’s receipt of the P roduct tha t such Produc t failed to
confor m, including a d etailed exp lanation in Eng lish of any alleg ed nonconfor mity; (ii) suc h Product is r eturned
to Medtr onic Neurosu rgery with in ninety (90) day s after Purc haser’s recei pt of the Produ ct F.O.B. 125 Cremona
Drive, Go leta, Calif ornia 93117, U.S.A. or as oth erwise de signated by Med tronic Neuro surgery; a nd (iii) Medtro nic
Neurosurgery is reasonably satisfied that the claimed nonconformities actually exist. Except as expressly provided
in this par agraph, Purc haser shall no t have the right to re turn Produ cts to Medt ronic Neurosu rgery wit hout
Medtronic Neurosurgery’s prior written consent.

C. Excl usion of Oth er Warrantie s. EXCEPT FOR THE LI MITED WARRANTY PR OVIDED IN (A) ABOVE,
MEDTRONIC NEU ROSURGERY GRANT S NO OTHER WARRANTIES O R CONDITIONS, EXPR ESS 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 OTHE R PERSON TO ASSUME AN Y OTHER LIABILITIES ARI SING OUT OF OR
IN CONNECTI ON WITH THE SALE OR USE OF ANY P RODUCT.