Cordis EMERALD™ Diagnostic Guidewire

Essential Prescribing Information

Indication

The Cordis EMERALD^™ Guidewire is intended for use in the percutaneous introduction of catheters.

Contraindication

None known

Warning

• Do not reuse.

Precautions

• Do not expose to organic solvents.
• Exposure to temperatures above 54ºC (130ºF) may damage the components.
• Do not withdraw a PTFE coated guidewire through a metal-cannula needle, as the coating may be damaged.
• If strong resistance is met during manipulation, determine the cause of the resistance before proceeding. If cause cannot be determined, withdraw the catheter and guidewire.

Adverse Events

• Procedure requiring percutaneous catheter/guidewire introduction should not be attempted by physicians unfamiliar with the possible complications. Adverse events may occur at any time during or after the procedure.
• Possible adverse events include, but are not limited to:
  • Air embolism
  • Hematoma at the puncture site
  • Infection
  • Perforation of the heart or vessel wall

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

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