Tabla de contenido
Publicidad
ENGLISH
ADVANCE MICRO™ 14 ULTRA LOW-PROFILE PTA
BALLOON 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 Micro 14 Ultra Low-Profile PTA Balloon 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 .014 inch (0.36 mm) wire guides.
The balloon surface has a hydrophilic coating which becomes slippery when
in contact with fluids.
INTENDED USE
The Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter has been designed
for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries
including internal pudendal, iliac, renal, popliteal, femoral, iliofemoral, anterior
tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as
obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for
use in the coronary arteries.
CONTRAINDICATIONS
None known
WARNINGS
• Do not exceed rated burst pressure.
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 below the
calculated rated burst pressure.
PRECAUTIONS
• The 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 Micro 14 Ultra Low-Profile PTA Balloon Catheter has been
designed for introduction into the vascular system utilizing percutaneous
(Seldinger) technique. 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.
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
Rupture of balloon may occur. Adhere
1
2
Publicidad
Tabla de contenido
