Merit Medical EmboCath Plus Infusion Microcatheter IFU: инструкция

Biosphere Medical, S.A.

Parc des Nations - Paris Nord 2

383 rue de la Belle Etoile

95700 Roissy en France

France

Manufactured for:

Merit Medical Systems, Inc.

1600 West Merit Parkway, South Jordan,

Utah 84095 U.S.A. 1-801-253-1600

U.S.A. Customer Service 1-800-356-3748

www.merit.com

730132002/A ID 100413

Instructions for use ....................... English ................................................. 2

Instructions d’utilisation ............... Français (French) ................................4

Инструкции за употреба .................Български (Bulgarian) ........................... 6

Pokyny pro použití ............................Čeština (Czech) ...................................... 8

Brugsanvisning ............................. Dansk (Danish) ..................................10

Gebruiksaanwijzing ...................... Nederlands (Dutch) ...........................12

Kasutusjuhised .............................. Eesti (Estonian) .................................14

Käyttöohjeet ................................... Suomi (Finnish) .................................16

Gebrauchsanweisungen ............... Deutsch (German) .............................18

Οδηγίες χρήσης .................................Ελληνικά (Greek) ................................. 20

Használati útmutató ...................... Magyar (Hungarian) ..........................22

Istruzioni per l’uso ......................... Italiano (Italian) ..................................24

Lietošanas norādījumi ......................Latviešu (Latvian) ...............................26

Naudojimo instrukcijos ................. Lietuviškai (Lithuanian) ....................28

Instruksjoner for bruk ................... Norsk (Norwegian) ............................ 30

Instrukcja stosowania ................... Polski (Polish) ...................................32

Instruções de utilização ................ Português (Portuguese) ................... 34

Instrucţiuni de utilizare ..................... Română (Romanian) ...........................36

Инструкции по применению ..........Русский (Russian) ...............................38

Návod na použitie .............................Slovenčina (Slovak) .............................40

Instrucciones de utilización ......... Español (Spanish) .............................42

Bruksanvisning.............................. Svenska (Swedish) ...........................44

Kullanma talimatları ...................... Türkçe (Turkish) ................................46

0459 - 2006

• Do not advance or withdraw against resistance. If

resistance is met, discontinue movement, determine

the reason for resistance, and take appropriate action

English

before continuing. Movement of the catheter or

guidewire against resistance may result in separation

DESCRIPTION

of the catheter or guidewire tip, damage to the

catheter, or vessel perforation.

®

The EmboCath

Plus Infusion Microcatheter is a tapered 3.0-

2.9F single lumen catheter designed to facilitate the

• Infusion dynamic pressure with this catheter

access of distal vasculature over a guidewire. The catheter

should not exceed 800 psi (54.4 atm/bar). The

has a semi-rigid proximal shaft and becomes progressively

static pressure with this catheter should not

more exible toward the distal end. The shaft is reinforced,

exceed 300 psi (20 atm/bar). Pressure in excess

which provides improved torque transmission. The inner

of these maximum pressures may result in catheter

lumen is lined with a lubricious material to facilitate the

rupture or device failure, possibly resulting in patient

movement of guidewires or other devices. The outer

or user injury. If the ow of material through the

diameter of the catheter is coated with a hydrophilic surface

catheter becomes restricted, do not attempt to clear

to enhance the ability to navigate tortuous anatomy. The

the catheter lumen by infusion. Identify and resolve

distal tip of the catheter has a single radiopaque marker to

the cause of the blockage or replace the catheter with

facilitate uoroscopic visualization. The hub at the proximal

a new catheter before resuming infusion.

end incorporates a standard luer adapter to facilitate the

• Excessive tightening of a hemostatic valve onto the

attachment of accessories. The catheter lumen is 0.028

catheter shaft may result in damage to the catheter.

inches and guidewires measuring up to 0.025 inches

• The hydrophilic coating has an extremely lubricious

(0.635 mm) in diameter are recommended.

surface only when properly hydrated.

INDICATIONS FOR USE

PRECAUTIONS

The EmboCath Plus Infusion Microcatheter is intended

• Do not expose Microcatheters to extreme

for: infusion of various diagnostic, embolic and therapeutic

temperatures or solvents.

agents into the body’s vascular systems (peripheral);

guidewire exchange/support; and superselective

• Prior to use, carefully examine the Microcatheter and

angiography of the peripheral vasculature. Diagnostic,

packaging to verify proper function and integrity.

embolic, or therapeutic agents are to be used according

to specications outlined by the manufacturer.

COMPLICATIONS

Note: Not intended for pediatric or neonatal use.

Procedures requiring percutaneous catheter introduction

should not be attempted by physicians unfamiliar with the

WARNING

possible complications listed below. Possible complications

may include, but are not limited to, the following:

• Contents supplied sterile.

• Puncture site hematoma

• Do not use if pouch is opened or damaged. Verify that

• Infection

the package integrity has been maintained to ensure

• Ischemia

the sterility of the device.

• Perforation of vessel or arterial wall

• Do not use in case of any surface irregularities,

• Vasospasm

bends, or kinks. Any damage of the micro-catheter

• Emboli

may change its characteristics likely to affect its

performance

Flow Rate Table

• Use the device prior to the “Use Before” date noted on

EmboCath Plus Infusion Microcatheter Flow Rate

the package.

(cc/second)

• For single patient use only.

Dead 100% 100%

Do not reuse, reprocess, or resterilize. Reusing ,

Length Space Saline Ionic Non-Ionic

reprocessing or resterilizing may compromise the

(cm) Volume Contrast Contrast

structural integrity of the device and or lead to device

(cc)

failure, which in turn may result in patient injury,

300 100 0.5 3.8 1.1 1.6

illness, or death. Reusing, reprocessing or resterilizing

psi 135 0.6 3.3 0.9 1.3

may also create a risk of contamination of the device

800 100 0.5 9.3 2.9 3.7

and or cause patient infection or cross infection

psi 135 0.6 7.0 2.3 3.0

including, but not limited to, the transmission of

Flow rate values are approximate

infectious disease(s) from one patient to another.

Contamination of the device may lead to injury,

illness or death of the patient.

PREPARATION FOR USE

• Discard the product after use.

• Open carefully the pouch

• This device should be used only by physicians

• Flush the hoop with sterile heparinized saline to

thoroughly trained in percutaneous, intravascular

activate the hydrophilic coating of the catheter.

techniques and procedures in relevant areas of the

The luer tting attached to the hoop will facilitate the

anatomy.

ushing of the hoop.

• Do not attempt to move the catheter without observing

• Flush the inner lumen of the catheter with

the catheter tip. Always maintain visualization of the

heparinized saline by attaching a saline-lled syringe

catheter under uoroscopy.

to the catheter hub.

2

• Remove the Microcatheter from the hoop. Repeat

between 60 and 75 minutes to a mixture of the

ushing of hoop if catheter is difcult to remove.

following agents: 5mg mytomicin, 25mg doxorubicin,

Inspect it prior to use to verify that it is undamaged

50mg cisplatin, 0.25g uorouracil, 5mL ethiodol, 5cc

sterile contrast and 1cc sterile water.

The hydrophilic infusion catheter must remain hydrated in

order to maintain lubricity.

BioSphere Medical assumes no liability with respect to

instruments reused, reprocessed or re-sterilized, and makes

no warranties, expressed or implied, including, but not limited

INSTRUCTIONS FOR USE

to, merchantability or tness for intended use with respect to

• The EmboCath Plus Infusion Microcatheter should be

such instrument.

utilized coaxially over a steerable guidewire. Follow

All serious or life threatening adverse events or deaths

the guidewire manufacturer’s instructions for use.

associated with use of EmboCath Plus should be reported

The catheter may be used with a guide catheter/

to the Competent Authority of the country where it occurred

sheath with a minimum internal diameter of 0.041

and to the device manufacturer.

in. (1.04mm). A rotating hemostatic valve used in

conjunction with the guiding catheter will provide a

uid-tight seal around the infusion catheter. Introduce

the infusion catheter and wire assembly through the

rotating hemostatic valve. Carefully tighten the valve

around the hydrophilic infusion catheter to prevent

backow, allowing some movement through the valve

by the hydrophilic infusion catheter.

Overtightening of a hemostatic valve may cause

damage to the catheter.

• Advance the guidewire and hydrophilic infusion

catheter to a selected vascular site by alternately

advancing the guidewire and then tracking the

hydrophilic infusion catheter over the guidewire.

Note: To facilitate catheter handling, the proximal portion

of the hydrophilic infusion catheter does not contain

the hydrophilic coating. Greater resistance may be en-

countered when this portion of the hydrophilic infusion

catheter is advanced into the rotating hemostatic valve.

• To infuse, completely remove the guidewire from

the hydrophilic infusion catheter. Connect a syringe

with infusate to the hydrophilic infusion catheter hub

and infuse as required. Do not inject any uid if air

bubbles are visible.

Information on packaging:

Note: Do not exceed Flow Rates/PSI as described in the

Flow Rate Table.

Symbol Designation

• Aspirate infusion catheter upon removal and discard.

Manufacturer: Name & Address

Use by date: year-month

CAUTION:

Batch code

P

Only: Federal (USA) law restricts this device to use by or

X

on the order of a licensed physician.

Catalogue number

Do not resterilize

CONTRAINDICATIONS:

Do not use if package is damaged

There are no known contraindications for the use of infusion

Keep away from sunlight

microcatheters.

Keep dry

STORAGE:

Do not re-use

Store the EmboCath Plus Infusion Microcatheter in a cool,

Caution -

dark, dry area.

Refer to Instructions For Use

Sterilized using ethylene oxide

COMPATIBILITY:

EC mark logo -

• The EmboCath Plus Infusion Microcatheter should be

Notied body identication : 0459

used with steerable guidewires that are up to 0.025

inches in diameter.

Maximum Guidewire

• The EmboCath Plus Infusion Microcatheter is

Maximum pressure

compatible with microspheres of size range 700-900

Radiopaque marker

μm and smaller.

• Catheters exhibited no detectable signs of material

degradation during bench testing when exposed

3