INVATEC IN.PACT PACIFIC Instrucciones De Uso página 6

DEVICE NAME
IN.PACT™ PACIFIC is a paclitaxel-eluting Balloon Dilatation Catheter
manufactured by Invatec Technology Center GmbH.
DESCRIPTION
The IN.PACT™ PACIFIC 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. 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. Maximum guide wire diameter is 0.018" (0.46 mm).
The IN.PACT™ PACIFIC is available in different balloon sizes. Nominal
balloon diameter and lengths are printed on the hub.
INDICATIONS
The IN.PACT™ PACIFIC is indicated for percutaneous transluminal
angioplasty (PTA) in patients with obstructive disease of peripheral
arteries.
CONTRAINDICATIONS
− The IN.PACT™ PACIFIC PTA catheter is contraindicated for the
use in coronary arteries and supra-aortic / cerebrovascular vessels.
− Inability to cross lesion with a guide wire.
− The IN.PACT™ PACIFIC should not be used in pregnant or breast
feeding women or in patients with known hypersensitivity to
paclitaxel.
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. The coating excludes any
reuse of the device.
− Inspect the device, prior to procedure, to verify functionality and
lack of damaged parts. Do not use the device if the outer or the
inner package is damaged or opened.
− To reduce the potential for vessel damage, the inflated diameter
of the balloon should approximate the diameter of the vessel just
distal to the stenosis.
− When the catheter is in the body, it should be manipulated
while under sufficient and/or high quality fluoroscopy. Prior to
withdrawing the balloon catheter from the lesion, the balloon
must be completely deflated under vacuum. If resistance is met
during manipulation, determine the cause of the resistance before
proceeding.
− Never use air or any gaseous medium to inflate the balloon. Use
only the recommended inflation medium.
− Do not expose the device to organic solvents, e.g. alcohol.
− 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 RPB is based
on the results of in vitro testing. At least 99.9% of the balloon
(with 95% confidence) will not burst at or below their RBP. Use
of a pressure monitoring device is recommended to prevent over
pressurization. Inflation in excess of the rated burst pressure may
cause the balloon to rupture.
− Only physicians thoroughly trained and educated in the
performance of PTA should use this device. Physicians should
keep themselves informed and updated on recent publications
IFU_In.Pact Pacific_0110095-3_multilanguage.indd 6
EN
2011-03-30 / 0110095-3
about PTA techniques.
− To reduce the risk of vessel damage, the inflated diameter of the
balloon should approximate the diameter of the vessel just distal
to the stenosis.
− 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 by the labeled date.
− Do not use with Lipiodol™ or Ethiodol™ contrast media (or other
such contrast media which incorporates the components of these
agents).
− Never apply positive pressure to the balloon during preparation.
PRECAUTIONS
− Appropriate drug therapy (anticoagulant, vasodilator, etc.) should
be administered to the patient according to standard protocols for
PTA before insertion of the dilatation catheter.
− 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.
− Precautions to prevent or reduce clotting should be taken when any
catheter is used. Flush or rinse all products entering the vascular
system with sterile isotonic saline or a similar solution via the
guidewire access port prior to use. Consider the use of systemic
heparinization.
− The IN.PACT™ PACIFIC 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.
− Catheter applications vary and the technique must be selected
on the basis of the patient's condition and the experience of the
interventionalist.
− Never advance the angioplasty catheter without the guidewire
extending from the tip.
− Never attempt to move the guidewire when the balloon is inflated.
− Do not advance the catheter against significant resistance. The
cause of resistance should be determined via fluoroscopy and
remedial action taken.
− Store at controlled room temperature, in a dry place. Keep away
from sunlight.
− Don't exceed dilatation pressures to "rated burst pressure". In any
case, always use a manometer controlled inflation.
CAUTION: Larger sizes of the IN.PACT™ PACIFIC PTA balloon catheter
may exhibit slower deflation times particularly on long catheter shafts.
POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
Complications associated with the use of the IN.PACT™ PACIFIC
balloon catheter are similar to the ones associated with standard PTA
procedures. Possible complications 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
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