Contraindications - INVATEC ADMIRAL XTREME Gebrauchsanleitung

DEVICE NAME
ADMIRAL™ XTREME is a PTA balloon catheter manufactured by
Invatec S.p.A.
DESCRIPTION
The ADMIRAL™ 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.
The ADMIRAL™ XTREME is available in different balloon sizes.
Nominal balloon diameter and lengths are printed on the hub.
INDICATIONS
The ADMIRAL™ XTREME is indicated for percutaneous transluminal
angioplasty (PTA) in patients with obstructive disease of peripheral
arteries.

CONTRAINDICATIONS

− The ADMIRAL™ XTREME PTA catheter is contraindicated for
the use in coronary arteries and supra-aortic vessels.
− It is also contraindicated when unable to cross the target lesion
with a guide wire.
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 to the „Use By" date specified on the
package.
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 damaged.
− To minimize the possible introduction of air into the system, it is
imperative that before proceeding careful attention is paid to the
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maintenance of tight catheter connections and through aspiration
and flushing of the system.
− ADMIRAL™ XTREME PTA balloon should be used with caution for
procedures involving calcified lesions or synthetic vascular graft
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
0.035" (0.89mm). Certain coatings on guide wires may lead to
increased friction between guide wire and catheter.
CAUTION: Larger sizes of ADMIRAL™ XTREME PTA balloon catheter
may exhibit slower deflation times particularly on long catheter shafts.
POTENTIAL COMPLICATIONS / ADVERSE EFFECTS
Possible complications associated with intravascular balloon catheter
implantation may include, but are not limited to:
Puncture related:
− Local hematoma
− Local hemorrhage
− Local or distal thromboembolic episodes
− Thrombosis
− Arterio-venous fistula
− Pseudoaneurysm
− Local infections
Dilatation related
− Dissection in the dilated artery wall
− Perforation of the artery wall
− Prolonged spasms
− Acute re-occlusion necessitating surgical intervention
− Restenosis of the dilated artery
− Total occlusion of the peripheral artery.
Angiography related
− Hypotension
− Pain and tenderness
− Arrhythmias
− Sepsis/infection
− Systemic embolization
− Endocarditis
− Short-term hemodynamic deterioration
− Death
− Drug reactions
− Allergic reaction to contrast medium
− Pyrogenic reaction
PREPARATION TECHNIQUE
Prior to use, carefully examine the unit to verify that the catheter or
sterile package has not been damaged in shipment. After moistening
the balloon protection sheath with physiological saline solution, carefully
remove the balloon protection sheath not to damage the balloon part.
In case of resistance, twist the protection with one hand holding the
shaft with the other.
CAUTION: Do not use with Lipiodol™ or Ethiodol™ contrast media, or
other such contrast media, which incorporate the components of these
agents.
TO DISPLACE AIR:
− Flush out the lumen for the guide wire by connecting a syringe filled
with saline solution. Start flushing until liquid rinses out of guidewire
lumen at the distal tip of the balloon catheter.
− Avoid manipulation of the balloon catheter during removal from
packaging and flushing of guide wire lumen.
INSERTION TECHNIQUE
− Access to the vessel must be sufficiently patent, or sufficiently
recanalized, to proceed with further intervention.
− In case the guide wire has not already been positioned across
the lesion, under fluoroscopy, insert a 0.035" (0.89mm) guide wire
across the lesion, following standard PTA techniques.
− Insert the proximal end of the guide wire into the distal tip of the
catheter.
− Carefully insert the PTA balloon catheter through the introducer
sheath and, under fluoroscopic guidance, carefully advance it
through the peripheral vasculature following the guide wire towards
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