Admiral™ Xtreme
PTA Balloon Catheter
Cathéter à ballonnet pour ATP
Instructions for Use • Mode d’emploi
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Trademarks may be registered and are the property of their respective owners.
Les marques commerciales peuvent être déposées et appartiennent à leurs propriétaires respectifs.
Symbols / Symboles
Consult Instructions for Use at this website: www.medtronic.com/manuals / Consulter le mode d'emploi sur ce
site Web : www.medtronic.com/manuals
Catalogue number / Numéro de catalogue
Lot number / Numéro de lot
Manufacturer / Fabricant
Manufactured in / Lieu de fabrication
Use-by date / Date de péremption
Sterilized using ethylene oxide / Stérilisé à l'oxyde d'éthylène
Caution / Attention
Do not reuse / Ne pas réutiliser
Do not resterilize / Ne pas restériliser
Keep dry / À conserver dans un endroit sec
Keep away from sunlight / Ne pas exposer à la lumière du soleil
Do not use if package is damaged / Ne pas utiliser si l'emballage est endommagé
Over the wire / Sur guide
Nominal pressure / Pression nominale
Rated burst pressure / Pression théorique de rupture
Maximum guidewire diameter / Diamètre maximum du fil-guide
Balloon diameter / Diamètre du ballonnet
Balloon length / Longueur du ballonnet
Minimum sheath inner diameter / Diamètre interne minimum de la gaine
Nonpyrogenic / Apyrogène
Quantity / Quantité
Do not exceed rated burst pressure / Ne pas dépasser la pression théorique de rupture
Inflation pressure / Pression de gonflage
Usable Catheter Length / Longueur utile du cathéter
1
Admiral™ Xtreme
PTA Balloon Catheter
1. Description
The Admiral Xtreme PTA balloon catheter is an over-the-wire (OTW) peripheral balloon catheter, specifically designed for
percutaneous transluminal angioplasty (PTA) in stenosed vessel segments. The catheter has a dual-lumen shaft that is
branched at the proximal end. One lumen forms the entrance to the central lumen for the guidewire, and the other lumen is
used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter and balloon
are designed to reach targeted inflation diameters, depending on the balloon size and defined pressure.
The Admiral Xtreme PTA balloon catheter is available in a variety of balloon sizes. The Compliance Chart included in the
catheter packaging lists the balloon diameters at given pressures.
The balloon catheter is provided with hydrophilic coating.
2. Indications
The Admiral Xtreme PTA balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal,
infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis
fistulae.
3. Contraindications
The Admiral Xtreme PTA balloon catheter is contraindicated for use in coronary arteries and in the neurovasculature. It is also
contraindicated for cases where the guidewire cannot cross the target lesion.
4. Warnings
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This device is designed and intended for single use only. DO NOT RESTERILIZE AND/OR REUSE. Reuse or resterilization
may create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited
to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury,
illness, or death of the patient. Reuse or resterilization may compromise the structural integrity of the device or lead to
device failure, which, in turn, may result in patient injury, illness, or death. Medtronic is not responsible for any direct,
incidental, or consequential damages resulting from resterilization or reuse.
■
To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the
vessel just proximal and distal to the stenosis.
■
When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic
observation.
■
Do not manipulate the balloon in its inflated state. The position of the balloon catheter may only be changed with the
guidewire in place.
■
If resistance occurs during manipulation, the cause must first be ascertained by fluoroscopy, road mapping, or DSA before
moving the balloon backward or forward.
■
Do not move the guidewire during inflation of the balloon.
■
Completely deflate the balloon before removing it from the vascular system.
■
Do not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99.9%
of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure-monitoring
device is recommended to prevent over pressurization.
■
Use only a mixture of contrast medium and saline solution to fill the balloon (1:1). Never use air or any gaseous medium to
inflate the balloon.
■
Use the catheter prior to the Use-by date specified on the package.
5. Precautions
■
Only interventionalists who have sufficient experience in percutaneous transluminal angioplasty should use this PTA
balloon catheter. A thorough understanding of the technical principles, clinical applications, and risks associated with
percutaneous transluminal angioplasty is necessary before using this product.
■
Administer appropriate drug therapy (anticoagulant, vasodilator, etc.) to the patient according to standard protocols for PTA
before inserting the dilatation catheter.
■
Exercise care during handling in order to avoid possible damage to the catheter. Do not use a catheter that has been
damaged.
■
To minimize the introduction of air, aspirate and flush the system and keep a tight catheter connection throughout the
procedure.
■
Use the device with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature
of these lesions.
2 Instructions for Use English