EUP4015X

Indications, Safety, and WarningsIndications

The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The balloon dilatation catheter (balloon models 2.00 mm to 4.00 mm) is also indicated for postdeployment expansion of balloon expandable stents.

Contraindications
The catheter is contraindicated for use in:

unprotected left main coronary artery

coronary artery spasm in the absence of significant stenosis

Warnings

For single patient, single procedure use only. Do NOT resterilize or reuse the device. Resterilization or reuse may compromise device performance and increase the risk of inappropriate resterilization and cross contamination.

Do not use the catheter if its package has been opened or damaged.

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.

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 catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum as this can potentially result in damage to the vessel wall. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

Balloon pressure should not exceed the rated burst pressure indicated on the package label for each balloon. The rated burst pressure is based on the results of in vitro testing. Use of a pressure monitoring device is recommended to prevent overpressurization.

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 prevent the possibility of an air embolus, never use air or any gaseous medium to inflate the balloon.

Use the catheter prior to the Use By date specified on the package.

Precautions

Prior to angioplasty, examine the catheter to verify functionality and ensure that its size and shape are suitable for the procedure for which it is to be used.

If the device is kinked, it should not be used.

The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.

Administer appropriate anticoagulation, antiplatelet, and vasodilator therapy to the patient.
Note: Testing without anticoagulation shows variable amounts of thrombus formation on the device surface. Thrombogenicity evaluations conducted using a heparinized model do not indicate thrombus formation. If the patient is not appropriately anticoagulated, thrombus formation may occur. Appropriate anticoagulation therapy should be administered to reduce potential thrombosis.

When using two guidewires, use caution when introducing, torquing, and removing one or both guidewires to avoid entanglement. It is recommended that one guidewire be completely withdrawn from the patient before removing any additional equipment.

Do not apply excessive force during preparation or use, as this may damage the device.

The safety and effectiveness of this PTCA balloon catheter for the treatment of instent restenosis (ISR) have not been established.

3.75 mm and 4.0 mm Euphora™ rapid exchange balloon models are not suitable for simultaneous use within a 2 mm [6F/MGCID 1.8 mm (0.070”)] guide catheter. Refer to Section 9.

Note: In the case of simultaneous use of two Euphora™ balloon catheters in 1 guide catheter, care should be taken when introducing, torquing and removing guide wires and balloon catheters to avoid entanglement.Adverse EventsPotential adverse effects seen during a PTCA procedure could be associated with this procedure. Possible adverse effects include, but are not limited to:

death

acute myocardial infarction

total occlusion of the coronary artery or bypass graft

coronary vessel dissection, perforation, rupture, or injury

restenosis of the dilated vessel

hemorrhage or hematoma

unstable angina

arrhythmias, including ventricular fibrillation

drug reactions or allergic reaction to contrast medium

hypotension/hypertension

infection

coronary artery spasm

arteriovenous fistula

stroke, air embolism, and embolization or fragmentation of thrombotic or athlerosclerotic material

Caution: Federal law (United States) restricts these devices to sale by or on the order of a licensed healthcare practitioner.See package inserts for the full product information.UC202311548 EN

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