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CONTRAINDICATIONS
• Unprotected left main coronary artery
• Coronary artery spasm in the absence of a significant stenosis
WARNINGS
• To reduce the potential for vessel damage, the inflated diameter of the balloon
should approximate, or be less than, the diameter of the vessel just proximal and
distal to the stenosis.
• PTCA in patients who are not acceptable candidates for coronary artery bypass graft
surgery requires careful consideration, including possible hemodynamic support
during PTCA as treatment of this patient population carries special risk.
• When the balloon catheter is exposed to the vascular system, it should only be
manipulated while under high-quality fluoroscopic observation. Do not advance
or retract the catheter unless the balloon is fully deflated and under vacuum. If
resistance is felt during manipulation, determine the cause of the resistance before
proceeding to avoid vessel damage.
• To reduce the risk of vessel injury, do not exceed the balloon rated burst pressure.
The rated burst pressure is based on the results of bench testing. At least
99.9 percent of the balloons (with 95 percent confidence) will not burst at or below
their rated burst pressure. Use of a pressure monitoring device is recommended to
prevent over or under pressurization causing balloon rupture, vessel damage or
inadequate dilation.
• PTCA should only be performed at hospitals where emergency coronary artery
bypass graft surgery can be quickly performed in the event of a potentially
injurious or life-threatening complication.
• Use only the recommended balloon inflation medium. To reduce the risk of air
embolism, never use air or any gaseous medium to inflate the balloon.
• Use the balloon catheter prior to the "Use By" date specified on the package.
• Used devices may pose a biohazard risk and must be handled and disposed of properly.
• Use extreme caution and careful judgment in patients for whom anticoagulation is
not indicated.
• Use extreme caution and careful judgment in patients who have severe reaction to
contrast agents that cannot be adequately pre-medicated.
• If difficulty is experienced during balloon inflation, do not continue; remove the
catheter to avoid vessel damage.
• Before withdrawing the balloon catheter, visually confirm complete balloon
deflation by fluoroscopy to avoid vessel damage.
• In the event of device separation balloon catheter retrieval methods (use of
additional wires, snares and/or forceps) may result in additional trauma to the
vascular access site. Complications can include but are not limited to bleeding,
hematoma, pseudoaneurysm, or dissection.
Note: If balloon burst occurs, carefully remove the catheter and assess the lesion for
potential vessel damage or embolization. If the device is kinked or damaged remove it
and replace with another device.
PRECAUTIONS
• Prior to angioplasty, the balloon catheter should be examined to verify functionality
and to ensure that its size and shape are suitable for the specific procedure for
which it is to be used.
Black (K) ∆E ≤5.0
• Before insertion of the balloon catheter, administer appropriate anticoagulant and
coronary vasodilator therapy.
• Care should be taken to control the position of guide catheter tip during
manipulation of the balloon catheter.
• Caution should be taken not to overtighten a hemostatic adapter around the catheter
shaft, as lumen constriction may occur, affecting inflation/ deflation of the balloon.
• When loading or exchanging the balloon catheter, it is recommended to thoroughly
wipe the guidewire clean for better catheter movement on the guidewire.
• Do not expand the balloon if it is not properly positioned in the vessel.
ADVERSE EVENTS
Potential adverse events (in alphabetical order) that may be associated with the use of
a PTCA dilatation catheter include, but are not limited to, the following:
• abrupt closure, slow flow/no reflow
• arrhythmia, including ventricular fibrillation or heart block
• bleeding, hemorrhage or hematoma
• cardiac arrest/cardiogenic shock
• cardiac tamponade/pericardial effusion
• cerebrovascular accident (stroke or transient ischemic attack)
• death
• drug reactions including allergy
• embolism (air, tissue, device fragments, plaque)
• hemodynamic compromise including vasovagal reaction
• infection
• myocardial ischemia or infarction
• organ insufficiency/failure (heart, lung, kidney)
• pain (angina)
• prolonged procedure time including additional intervention or surgery
• radiation injury
• restenosis of the dilated vessel
• thrombosis
• vessel injury (spasm, dissection, perforation, rupture, arteriovenous fistula,
pseudoaneurysm)
HOW SUPPLIED
Device Details
Contents supplied sterile using an ethylene oxide (EO) process. Do not use if package
is damaged or unintentionally opened before use. If damage is found, call your
Boston Scientific representative. Do not use if labeling is incomplete or illegible.
Handling and Storage
This product has no special handling or storage requirements.
OPERATIONAL INSTRUCTIONS
Additional Items for Safe Use
Material Required for PTCA with the Maverick
4
2
Monorail PTCA Dilatation Catheter
MB Drawing 50573139
M
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