Cordis AVANTI®+ Sheath Introducer

Essential Prescribing Information

Indication

Indicated for use in arterial procedures requiring percutaneous introduction of intravascular devices.

Contraindication

None known.

Warnings

  • For single use only. Do not resterilize or reuse.
  • Do not use with Ethiodol* or Lipiodol* contrast media or other contrast media that incorporates the components of these agents.
  • Do not leave sheath introducer in place for extended periods of time without a catheter or obturator to support the cannula wall.

Precautions

  • Exposure to temperatures above 54ºC (130ºF) may damage the catheter sheath and components.
  • Do not expose to organic solvents, (e.g. alcohol).
  • If increased resistance is felt upon insertion of the catheter sheath introducer (CSI), investigate the cause before continuing. If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the catheter sheath introducer.

Adverse Events

  • Possible adverse events include, but are not limited to:
    • air embolism
    • hematoma at the puncture site
    • infection
    • perforation of the vessel wall
    • intimal tear
    • thrombus formation

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.