INVATEC Pacific Xtreme Instrucciones De Uso página 5

DESCRIPTION
The PACIFIC™ XTREME is an Over the Wire (OTW) peripheral
balloon catheter, specifically designed for percutaneous transluminal
angioplasty in atherosclerotic obstructed vessels. The catheter has
a dual-lumen shaft, onto the distal tip of which a balloon is welded.
The double-lumen shaft is branched at the proximal end so that one
tube forms the entrance to the central lumen for the guide wire, while
the other tube is used to inflate and deflate the dilatation balloon
with a mixture of contrast medium and saline solution. The catheter
construction and the special balloon material are designed so that a
specific balloon diameter can be reached, depending on the balloon
size and defined pressure. The length of each balloon is specified.
A hydrophilic coating has been specifically designed to cover this distal
segment, lubricating the catheter when wet. The PACIFIC™ XTREME
is available in different balloon sizes. Nominal balloon diameter and
lengths are printed on the hub. A needle to facilitate the insertion of the
0,018" guidewire and a clip to aid catheter handling is provided in the
sterile packaging.
INDICATIONS
The PACIFIC™ XTREME is indicated for percutaneous transluminal
angioplasty (PTA) in patients with obstructive disease of peripheral
arteries, i.e. Ilio-femoral-, femoral-, popliteal-, infra-popliteal- and renal
arteries.
PACIFIC™ XTREME for carotid and supra-aortic applications
Only balloon catheters with diameters from 2 to 7 mm and lengths from
20 to 40 mm are indicated for carotid and supra-aortic applications.
CONTRAINDICATIONS
− The PACIFIC™ XTREME PTA catheter is contraindicated for the
use in coronary arteries.
− The PACIFIC™ XTREME PTA catheter with diameters from 2 to
7mm and balloon lengths of more than 40 mm is contraindicated
for the use in carotid and supra-aortic arteries.
WARNINGS
− 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 cross-infection, including, but not limited to, the
transmission of infectious disease(s) 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 and/or lead to device failure which, in turn,
may result in patient injury, illness and death. INVATEC will not be
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 PTA balloon is exposed to the vascular system, it should
be manipulated while under high-quality fluoroscopic observation.
− Do not manipulate the PTA balloon in inflated state. The position of
the PTA balloon 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
the balloon catheter is moved backwards or forwards.
− The guidewire may under no circumstances be moved during
inflation of the PTA balloon.
− The balloon must be completely deflated before retrieving the
catheter from the vascular system.
− Do not exceed the Rated Burst Pressure (RBP). The RBP 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 of the catheter.
− Use the catheter prior the "Use By" date specified on the package.
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− Do not use with Lipiodol™ or Ethiodol™ contrast media (or other
such contrast media which incorporates the components of these
agents).
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.
− Appropriate drug therapy (anticoagulant, vasodilator, etc.) should
be administered to the patient according to standard protocols
for PTA before insertion of the dilatation catheter.
− Exercise care during handling in order to avoid possible damage
to the catheter. Do not use a catheter that has been kinked or
damaged.
− To minimize the possible introduction of air into the system, it is
imperative that before proceeding careful attention is paid to the
maintenance of tight catheter connections and through aspiration
and flushing of the system.
− PACIFIC™ XTREME PTA balloon should be used with caution for
procedures involving calcified lesions due to the abrasive nature
of these lesions.
− Allergic reactions to contrast medium should be identified before
treatment.
− The general technical requirements for catheter insertion must
be observed at all times. This includes flushing the components
with sterile, isotonic saline solution prior to use and the usual
prophylactic, systemic heparinization.
− Catheter applications vary and the technique must be selected
on the basis of the patient's condition and the experience of the
interventionalist.
− The maximal diameter of the guide wire must not exceed over
0.018" (0.46mm). Certain coatings on guide wires may lead to
increased friction between guide wire and catheter.
CAUTION: Larger sizes of PACIFIC™ XTREME PTA balloon catheter
may exhibit slower deflation times particularly on long catheter shafts.
PRECAUTIONS FOR CAROTID AND SUPRA-AORTIC APPLICATIONS
During or after the use of a balloon catheter to dilate a stenotic lesion
in carotid arteries, peripheral embolization of thrombotic or sclerotic
material may occur. To minimize the possibility of these major
complications generally leading to TIA's, PRIND's or strokes, it is
therefore recommended to:
Only physicians thoroughly trained and educated in the performance in
the endovascular treatment of Carotid arteries should use this device.
Physicians should keep themselves informed and updated on recent
publications about Carotid artery treatment.
− Minimise trauma during manipulation of guiding catheter or guide
wire preceding dilatation.
− Apply lesion focalised dilatations using appropriate inflation time.
− In case of post-dilatation of an implanted stent, pass the stented
area gently.
ADVERSE EFFECTS
Complications associated with the use of PACIFIC™ XTREME
are similar to the ones associated with standard PTA procedures.
Complications may occur at any time during or after procedure.
Potential complications may include, but are not limited to:
Puncture-related:
− Hematoma at puncture site
− Hemorrhage at puncture site
− Thrombo-embolization
− Venous thrombosis
− Arterio-venous fistula
− Spurious aneurysm
− Local infections
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