Modified Hydrophilic Coated Guidewire Stainless Steel Core

FDA-Cleared Indications

• Intended for use in procedures involving liquid embolization agents.
• Used to facilitate catheter navigation and placement during vascular interventions.
• The device is a catheter guidewire classified under 21 CFR 870.1330, Wire, Guide, Catheter.

Clinical Applications

• Guiding a catheter during vascular procedures that use liquid embolization agents.
• Facilitating catheter placement within selected blood vessels.
• Providing wire support during minimally invasive vascular access and intervention when used according to the manufacturer's labeling.

Reported off-label uses

• Guidewire assistance during angiography, when consistent with the wire's size, compatibility, and manufacturer instructions.
• Guidewire support during selected endovascular procedures such as stent delivery or vessel embolization, when the specific product labeling does not list that application.

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

• Confirm the guidewire diameter, length, tip configuration, and stiffness are compatible with the catheter, introducer sheath, and planned anatomy.
• Activate and maintain the hydrophilic coating with sterile saline according to the manufacturer's instructions; a dry coating may increase friction and damage risk.
• Use fluoroscopic or other appropriate imaging guidance and advance without force. Resistance may indicate vessel spasm, dissection, perforation, device entanglement, or incompatibility.
• The stainless steel core and coating do not by themselves establish MRI safety. Check the exact product labeling for MR Safe, MR Conditional, or MR Unsafe status before MRI exposure.
• Potential complications include vessel injury, perforation, dissection, thrombosis, embolization, infection, coating separation, and guidewire fracture or retention. Do not use if the package or device is damaged, and follow sterile handling requirements.