Cordis FIRE STAR® PTCA
Dilatation Catheters

Essential Prescribing Information

Indications

The Cordis FIRE STAR® RX PTCA 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.

Contraindications

  • Unprotected left main coronary artery lesions.
  • Coronary artery spasm in the absence of a significant stenosis.

Warnings

  • For single patient use only. 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.
  • 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 the procedure, 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. If resistance is felt during manipulation, determine the cause of the resistance before proceeding.
  • Balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization.
  • 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 the catheter before the “Use By” date specified on the package.
  • During withdrawal of the PTCA catheter, hold a saline soaked gauze around the exposed catheter shaft and pull the catheter through the gauze to remove blood or any other residues.
  • Care should be taken when handling the distal part of the catheter (including the balloon) to prevent damages and prematurely removing balloon cover.
  • Do not use if the inner package is open or damaged. Carefully remove the PTCA catheter from the pouch.
  • Do not use with Ethiodol* and Lipiodol* contrast media, or other such contrast media, which incorporate the components of these agents. Never use air or any gaseous medium to inflate the balloon.
  • If a Tuohy-Borst type adjustable hemostasis valve is used, avoid overtightening since this action may restrict the flow of contrast medium in and out of the inflation lumen, thereby slowing inflation/deflation.

Precautions

  • Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific 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 (PTCA).
  • Appropriate anticoagulant/antiplatelet therapy should be used during this procedure.
  • Prior to insertion or withdrawal of the PTCA catheter, wipe the guidewire with saline soaked gauze to remove blood or other residues.
  • Nonionic contrast medium has different viscosity and precipitation levels than does ionic contrast, which may prolong inflation/deflation times.
  • Fully deflate the balloon by inducing negative pressure with the inflation system whenever advancing or withdrawing the PTCA catheter.
  • Do not advance or withdraw the PTCA catheter within the coronary vasculature unless it is preceded by a guidewire.
  • Care should be taken when inserting the PTCA catheter into the hemostasis valve in order to avoid kinking.

Adverse Effects

Possible adverse effects include, but are not limited to the following:

  • 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, allergic reaction to contrast medium
  • hypo/hypertension
  • infection
  • coronary artery spasm
  • arteriovenous fistula
  • embolism

Important Information
Prior to use, refer to the "Instruction for Use" supplied with these devices for indications, contraindications, adverse events, suggested procedures, warnings and precautions.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

*The third-party trademarks used herein are trademarks of their respective owners.