SPL30010X

Sprinter™ Legend™ RX semicompliant balloon dilatation catheter

Indications, Safety, and WarningsIndicationsThe 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 2.25 mm through 4.0 mm) is also indicated for post-delivery expansion of balloon-expandable stents.Note: Bench testing was conducted with the Sprinter™ Legend™ rapid exchange balloon dilatation catheter and marketed balloon-expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.ContraindicationsThe 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 and/or reuse it, as this can potentially result in compromised device performance and increased 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 (expiration date) specified on the package.

Precautions

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

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

Appropriate anticoagulation, antiplatelet, and vasodilator therapy should be administered to the patient.

When using two guidewires, care should be taken 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.

3.75 mm and 4.0 mm Sprinter™ Legend™ rapid exchange balloon models are not suitable for simultaneous use within a 2 mm (6 Fr / MGCID 1.8 mm [0.070 in]) guide catheter. Refer to section 9.

Note: In the case of simultaneous use of two Sprinter™ Legend™ balloon catheters in one guide catheter, care should be taken when introducing, torquing, and removing guidewires and balloon catheters to avoid entanglement.

Care should be taken not to position two Sprinter™ Legend™ balloon catheters in one vessel as inflation in this position may damage the device.

Care should be taken not to apply excessive force during preparation or use as this may damage the device.

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

When inflating the balloon catheter, observe the pressure monitoring device and/or fluoroscopic image for any loss in pressure. If loss in pressure is observed, cease inflating, apply negative pressure to fully deflate the balloon, remove the balloon catheter, and inspect the system for possible leaks.

Caution: Federal law (United States) restricts these devices to sale by or on the order of a licensed healthcare practitioner.

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