COOK Medical Advance 35 LP, Инструкция по эксплуатации

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ENGLISH
ADVANCE® 35LP LOW PROFILE
PTA BALLOON DILATATION CATHETER
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Advance 35LP Low Profile PTA Balloon Dilatation Catheter is a double-
lumen catheter with a balloon near its distal tip. The catheter consists of two
independent lumens, which are labeled “DISTAL” and “BALLOON.” The distal
lumen extends the length of the catheter and is used for placement of wire
guides. The balloon lumen is used to expand the balloon. Inscribed on the tip
of the manifold are the balloon diameter (mm) and the balloon length (cm).
The balloon is manufactured from an extra-thinwall, high-strength, minimally-
compliant material. Particular care should be taken in handling the balloon
to prevent damage. It will inflate to the indicated size parameters when
utilizing proper pressure recommendations. Adhere to balloon inflation
pressure parameters indicated in the Compliance Card insert. Refer to label
for further information. Use of a pressure gauge is recommended to monitor
inflation pressures.
Platinum/iridium, radiopaque markers are positioned on the shaft within the
balloon to enable visualization of the catheter/balloon under fluoroscopy. The
catheter is compatible with .035 inch (0.89 mm) wire guides.
INTENDED USE
The Advance 35LP Low Profile PTA Balloon Dilatation Catheter is indicated for
percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries
including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well
as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
CONTRAINDICATIONS
None known
WARNINGS
• Do not exceed rated burst pressure. 1 Rupture of balloon may occur. Adhere
to balloon inflation pressure parameters in the Compliance Card insert.
Over-inflation may cause rupture of the balloon, with resultant damage
to the vessel wall. Use of a pressure gauge is recommended to monitor
inflation pressures.
• Do not use a power injector for balloon inflation or injection of contrast
medium through catheter lumen marked “DISTAL.” Rupture may occur.
1
The burst pressure data was analyzed using factors for a one-sided tolerance to
determine with 95% confidence that 99.9% of these balloons would not burst at or below
the calculated rated burst pressure.
PRECAUTIONS
• This product is intended for use by physicians trained and experienced
in diagnostic and interventional techniques. Standard techniques for
placement of vascular access sheaths, angiographic catheters and wire
guides should be employed.
• The Advance 35LP Low Profile PTA Balloon Dilatation Catheter has been
designed for introduction into the vascular system utilizing percutaneous
(Seldinger) technique. Alternatively, an introducer sheath may be utilized.
Refer to label information for the appropriate introducer sheath size.
• The balloon is constructed of a heat-sensitive material. Do not heat or
attempt to shape the catheter tip.
• In heavily scarred access sites, use of an introducer sheath is recommended.
• Manipulate the catheter using fluoroscopic control.
• Use only the recommended balloon inflation medium. Never use air or any
gaseous medium to inflate the balloon.
• Use the catheter prior to the expiration date specified on the package.
• The catheter is not intended for the delivery of stents.
• All stents should be deployed in accordance with the manufacturer‘s
indications and instructions for use.
POTENTIAL ADVERSE EVENTS
• Air embolism
• Aneurysm
• Arrhythmias
• Arteriovenous fistula
• Death
• Drug reactions, allergic reaction to contrast medium
• Hemorrhage or hematoma
• Hypo/hypertension
• Infection and pain at insertion site
• Systemic embolization
• Vascular thrombosis
• Vessel dissection, perforation, rupture or injury
• Vessel spasm
INSTRUCTIONS FOR USE
Balloon Preparation
1. Choose a balloon appropriate to lesion length and vessel diameter.