Introducer Percutaneous -- Modification

FDA-Cleared Indications

• Percutaneous introduction of catheters or other medical devices into the vascular system.
• Use as an introducer or access conduit during vascular interventional procedures.

Clinical Applications

• Providing percutaneous vascular access for catheter-based embolization procedures.
• Establishing an access pathway for diagnostic or therapeutic vascular catheters.
• Supporting minimally invasive procedures in which vascular access is required.

Reported off-label uses

• Use as an access conduit during selected nonvascular interventional procedures when the device's physical characteristics are appropriate; this is not necessarily covered by the FDA labeling.

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 introducer size, length and configuration depend on the access vessel, catheter diameter and procedure.
• Device compatibility should be confirmed with the intended guidewire, catheter and other interventional equipment before use.
• Insertion is typically performed percutaneously with imaging guidance and sterile technique; vascular injury, bleeding, infection, thrombosis and embolization are potential risks.
• MRI safety depends on the specific device materials and labeling. The exact model should be checked in the manufacturer's instructions before MRI.
• Contraindications and precautions include uncontrolled bleeding risk, local or systemic infection, unsuitable vascular anatomy and inability to safely obtain vascular access.