Medtronic PCU040250130 Instructions for Use
Instructions for use • Mode d’emploi
CAUTION: Federal (USA) law restricts this product for sale by or on the order of a physician.
Manufacturer / Fabricant
Medtronic, Inc., Minneapolis, MN
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1. DESCRIPTION
The PACIFIC XTREME™ is an over-the-wire
(OTW) peripheral balloon catheter, specically
designed for percutaneous transluminal
angioplasty in stenosed vessel segments. The
catheter is a Coaxial dual lumen device. The
lumen marked “WIRE” is the central lumen
of the catheter, which terminates at the distal
tip. This lumen is used to pass the catheter
over a guide wire with a maximum outer
diameter of 0.018 in (0.46 mm). The lumen
marked “BALLOON” is the balloon ination
lumen, which is used to inate and deate the
dilatation balloon with a mixture of contrast
medium and saline solution.
Consult the Compliance Chart which is
included in the catheter packaging for the
diameters of the balloons at given pressures.
The length of each balloon is specied. The
PACIFIC XTREME is available in dierent
balloon sizes. The balloon catheter is
provided with hydrophilic coating.
2. INDICATIONS
The PACIFIC XTREME PTA Balloon Dilatation
Catheter in 150 mm, 200 mm, 250 mm, and
300 mm balloon length is intended to dilate
stenoses in the femoral, popliteal, and infrapopliteal arteries.
3. CONTRAINDICATIONS
The PACIFIC XTREME PTA catheter is
contraindicated for the use in coronary
arteries or the neurovasculature. It is also
contraindicated when unable to cross the
target lesion with a guidewire.
4. 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
crossinfection, 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,
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illness, or death. Medtronic will not be
responsible for any direct, incidental, or
consequential damages resulting from
resterilization or reuse.
• To reduce the potential for vessel damage,
the inated 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 uoroscopic
observation.
• Do not manipulate the PTA balloon in
inated state. The position of the PTA
balloon may only be changed with the
guidewire in place.
• If resistance occurs during manipulation,
the cause must rst be ascertained by
uoroscopy, road mapping or DSA before
the balloon catheter is moved backwards
or forwards.
• The guidewire may under no circumstances
be moved during ination of the balloon.
• The balloon must be completely deated
before removing the catheter from the
vascular system.
• Do not exceed the Rated Burst Pressure
(RBP). The Rated Burst Pressure is
based on the results of in-vitro testing. At
least 99.9% of the balloons (with a 95%
condence) will not burst at or below their
rated burst pressure. Use of a pressuremonitoring device is recommended to
prevent over pressurization.
• Use only a mixture of contrast medium and
saline solution to ll the balloon (1:1). Never
use air or any gaseous medium to inate
the balloon.
• Use the catheter prior to the “Use By” date
specied on the package.
5. PRECAUTIONS
• Only Interventionalists who have sucient
experience should carry out Percutaneous
Transluminal Angioplasty with this balloon
catheter. A thorough understanding of the
technical principles, clinical applications,
and risks associated with Percutaneous
Transluminal Angioplasty is necessary
before using this product.
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• 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
maintenance of tight catheter connections
and through aspiration and ushing of the
system.
• PACIFIC XTREME PTA balloon should be
used with caution for procedures involving
calcied lesions due to the abrasive nature
of these lesions.
• Allergic reactions to contrast medium
should be identied before treatment.
• The general technical requirements for
catheter insertion must be observed
at all times. This includes ushing 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 in (0.46 mm).
Certain coatings on guide wires may lead
to increased friction between guide wire
and catheter.
CAUTION: Larger models of PACIFIC
XTREME PTA balloon catheter may exhibit
slower deation times particularly on long
catheter shafts.
6. POTENTIAL COMPLICATIONS /
ADVERSE EFFECTS
The complications that may result from a
balloon dilatation procedure include:
Puncture related:
• Local hematoma
• Local hemorrhage
• Local or distal thromboembolic episodes
• Thrombosis
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• Arterio-venous stula
• 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
7. 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. In case of resistance, twist the
protection sheath with one hand, holding the
shaft with the other.
CAUTION: Do not use with Lipiodol contrast
media, or other such contrast media, which
incorporate the components of these agents.
TO DISPLACE AIR:
1. Flush out the lumen for the guidewire by
connecting a syringe lled with saline
solution. Start ushing until liquid rinses
out of guidewire lumen at the distal tip of
the balloon catheter.
2. Connect a syringe containing contrast
medium to the Luer connector located at
the proximal hub of the balloon catheter
and apply negative pressure for about
15 seconds until no bubbles appear in
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