Boston Scientific Maverick2 MONORAIL Gebrauchsanweisung Seite 3

Maverick
M O N O R A I L ™
PTCA Dilatation Catheter
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
REUSE WARNING STATEMENT
For single patient use only. There has been no testing to validate this device beyond
use in a single patient. Do not reuse, reprocess or resterilize. Reuse, reprocessing 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 or death. Reuse,
reprocessing or resterilization may also 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.
DEVICE DESCRIPTION
Device Name
Boston Scientific Maverick
of the device is rapid exchange Percutaneous Transluminal Coronary Angioplasty
Dilatation Catheter.
Description
The Maverick Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA)
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Dilatation Catheter, from Boston Scientific, is a rapid exchange catheter with a balloon
near the distal tip. The distal section of the catheter is dual lumen and coaxial. The
outer lumen is used for inflation of the balloon, and the inner lumen permits the use of
≤0.014 in (0.36 mm) guidewires to facilitate advancement of the catheter to and
through the stenosis to be dilated. The proximal section of the catheter is a single
lumen, stainless steel hypotube with a single luer port for inflation/deflation of the
balloon. The balloon is designed to provide an inflatable segment of known diameter
and length at recommended pressures. A balloon protector is placed over the balloon
to maintain a low profile and a mandrel is placed into the lumen to protect the patency.
The catheter includes a tapered tip to facilitate advancement of the catheter to and
through the stenosis. In addition, a hydrophilic coating is applied from the distal tip
to the guidewire port for increased lubricity on the 15 mm, 20 mm, 25 mm, and 30 mm
length balloons. To prevent auto-adhesion of this hydrophilic coating on the balloon,
a silicone coating is applied from the distal tip to just proximal of the balloon over
the hydrophilic coating. The 9 mm and 12 mm balloon length models are only coated
with the silicone coating from the distal tip to just proximal of the balloon to prevent
the balloon from moving relative to the lesion during balloon inflation. The 1.5 mm
Maverick Monorail PTCA Dilatation Catheter models have one radiopaque marker
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band while all other Maverick
radiopaque markers that, in conjunction with fluoroscopy, aid in the placement of the
catheter's balloon segment. A CLIPIT
The Maverick 2 Monorail PTCA Dilatation Catheter is a non-pyrogenic device.
39 MB Drawing 50573139
2™
Monorail PTCA Dilatation Catheter. The generic name
2
2 Monorail PTCA Dilatation Catheter models have two
Clip is provided to aid in handling of the catheter.
TM
Contents
• One (1) Maverick Monorail PTCA Dilatation Catheter
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• One (1) CLIPIT Clip
Operating Principle
PTCA is a technique that involves enlargement of a narrowed coronary artery with an
inflatable balloon attached to the distal tip of a catheter. During the procedure, while the
balloon is deflated, the catheter is inserted into the narrowed coronary artery through
a small opening in the femoral or radial artery. Once positioned inside the narrowed
artery, the balloon is inflated, and the inner lumen of the artery is enlarged so that
blood can flow more easily. The balloon is then deflated, and the catheter is removed.
Similarly, the balloon catheters can also be used for the postdelivery expansion of
balloon expandable stents.
Materials
Maverick Monorail has a proximal PTFE-coated stainless steel hypotube and distal
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bioslide hydrophilic coating. The distal portion of the inner catheter has a gold marker
band for radiopacity. Maverick 2 Monorail has a polymer shaft and polymer balloon.
Contains cobalt: CAS No. 7440-48-4; EC No. 231-158-0. Defined as a 1B
carcinogen and reproductive toxicant according to the European Commission in
a concentration above 0.1% weight by weight.
Note: This device is made with a metal alloy which contains cobalt. Current
scientific evidence supports that metal alloys containing cobalt used in medical
devices, do not cause an increased risk of cancer or adverse reproductive effects.
Non-Pyrogenic
The Maverick 2 Monorail PTCA Dilatation Catheter is non-pyrogenic.
User Information
Physicians experienced in interventional cardiology procedures.
INTENDED USE/INDICATIONS FOR USE
• The Maverick Monorail PTCA Dilatation Catheter is intended for balloon dilation of
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the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of
improving myocardial perfusion.
• The Maverick Monorail PTCA Dilatation Catheter (balloon models 2.25 mm - 4.0 mm)
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is also intended for the post-delivery expansion of balloon expandable stents.
Note: Bench testing was conducted with the Maverick
Catheter and marketed Boston Scientific balloon expandable stents. Consideration
should be taken when this device is used with other manufacturers' stents due to
differences in stent design.
CLINICAL BENEFIT STATEMENT
The Maverick Monorail PTCA Dilatation Catheter is a minimally invasive medical device
2
used for the purpose of dilating coronary artery stenoses to improve myocardial
perfusion in patients with stenotic coronary lesions.
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
For customers in the European Union, use the device name found in the labeling to search for
the device's Summary of Safety and Clinical Performance, which is available on the European
database on medical devices (EUDAMED) website: (https://ec.europa.eu/tools/eudamed).
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Monorail PTCA Dilatation
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Black (K) ∆E ≤5.0