Braun Percutaneous Introducer Set

FDA-Cleared Indications

• Facilitation of percutaneous vascular access for the introduction of catheters and other vascular devices.
• Use during interventional procedures requiring access to the vascular system, including embolization procedures.

Clinical Applications

• Percutaneous arterial or venous access for catheter-based vascular procedures.
• Vascular access during embolization procedures.
• Placement of catheters or other compatible devices into the vascular system under image guidance.

Reported off-label uses

• Access for non-embolization endovascular procedures, such as diagnostic angiography or vascular interventions, when the specific set configuration and labeling are appropriate.
• Access for selected neurointerventional procedures, such as cerebral angiography or aneurysm treatment, when used according to institutional technique and compatible device requirements.

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 set is available in different sheath diameters and lengths; the appropriate size depends on the access vessel, catheter system, and procedure.
• Clinicians should confirm compatibility with the guidewire, catheter, embolic device, and other equipment used during the procedure.
• Placement is usually performed with sterile technique and fluoroscopic or ultrasound guidance, depending on the access site and procedure.
• Potential access-site complications include bleeding, hematoma, infection, arterial or venous injury, thrombosis, and, rarely, vessel perforation.
• MRI safety depends on the specific components and whether any part remains in the patient; the product labeling should be checked before MRI. A temporary sheath removed at the end of a procedure is not the same as an implanted device.