Introducer Catheter

FDA-Cleared Indications

• Facilitate insertion of other catheters into the vascular system.
• Provide vascular access for procedures requiring placement of catheters.
• Use in vascular access situations such as hemodialysis or cardiac catheterization when indicated by the product labeling.

Clinical Applications

• Vascular access during cardiac catheterization and cardiac surgery.
• Access for hemodialysis when an arteriovenous shunt is not feasible.
• Placement of diagnostic or therapeutic catheters through a vascular access route.

Reported off-label uses

• Access sheath or catheter introduction during interventional radiology embolization procedures.
• Vascular access during selected endovascular procedures involving arterial or venous catheter placement.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The appropriate diameter and length depend on the target vessel, access site, and catheter or device that must pass through the introducer.
• Use only compatible guidewires, dilators, catheters, and accessories specified in the product instructions for use.
• Insertion is generally performed using sterile technique and imaging guidance, such as ultrasound and fluoroscopy, depending on the procedure.
• Potential complications include bleeding, infection, vessel injury, thrombosis, air embolism, and loss of access; serious or fatal events are rare but possible.
• MRI compatibility cannot be determined from the FDA record alone. Check the exact product labeling before MRI, and remove or manage the device according to its instructions for use.