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Indications, Safety and Warnings

Site Selective Pacing Catheter – FGD 92387032 Rev H (H.4)

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INDICATIONS FOR USE

The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.

CONTRAINDICATIONS

  • Obstructed or inadequate vasculature for venous access

WARNINGS

  • Do not advance Deliver Catheter against resistance without careful assessment of the cause of resistance under fluoroscopy.
  • Do not advance a lead or catheter through the Delivery Catheter against resistance without careful assessment of the cause of resistance under fluoroscopy.
  • Do not remove the Deliver Catheter or a lead or catheter placed through the Deliver Catheter against resistance without careful assessment of the cause of resistance under fluoroscopy.
  • Do not resterilize or reuse. Structural integrity and/or function may be impaired by cleaning, resterilisation, or reuse.
  • Do not expose the device to the MR Environment

PRECAUTIONS

  • The Delivery Catheter should be used by interventionalists experienced in performing cardiovascular procedures.
  • Do not use if package is open or damaged.
  • Use by “Use By” date.
  • Exposure to temperatures above 54°C (130°F) may damage device and accessories.
  • Upon removal from package, inspect device to ensure no damage has occurred during shipping.
  • Do not expose to solvents.
  • Use in conjunction with fluoroscopic guidance and proper anti-coagulation agents.
  • Ensure the catheter is thoroughly flushed and free of air prior to use.
  • Care should be taken during the procedure to ensure that the hemostatic valve is not damaged and that the side port remains closed to reduce potential for air Ingress or blood loss.

COMPLICATIONS

Possible complications include, but are not limited to, the following: exposure to x-ray radiation, adverse or allergic reactions to contrast agents, infection, hematoma, pneumothorax, embolization, vessel thrombosis, dissection, acute occlusion, clot formation, hemorrhage, vessel rupture, arrhythmia or heart block, hemodynamic changes, myocardial infarction, perforation of the heart, cardiac tamponade, stroke, and death.

92436226 B.3

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