Modified Hydrophilic Coated Guidewire

FDA-Cleared Indications

• Used to facilitate the introduction and positioning of catheters within the vascular system.
• Used to assist catheter navigation during diagnostic or interventional vascular procedures.
• The FDA record identifies the device category as a catheter guidewire under 21 CFR 870.1330, product code DQX.

Clinical Applications

• Guiding catheters during central venous access procedures.
• Assisting vascular catheter placement and navigation under fluoroscopic or other imaging guidance.
• Supporting access for diagnostic angiography and endovascular interventions when compatible with the selected catheter.
• Providing a lubricious guide surface to help advance compatible catheters through the vasculature.

Reported off-label uses

• Guidewire assistance in selected nonvascular procedures, such as ureteral access, may occur in clinical practice, but this should not be assumed to be covered by the FDA vascular labeling.
• Use in specialized access techniques outside the cleared labeling may be considered only by qualified clinicians under appropriate institutional policies.

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

• Select the wire diameter, length, tip shape and stiffness to match the access site, target anatomy and compatible catheter.
• Hydrophilic coatings require activation according to the product instructions, usually with sterile fluid; avoid allowing the coating to dry during use.
• Use imaging guidance and maintain wire control to reduce the risk of vessel perforation, dissection, entanglement or loss of access.
• MRI safety depends on the exact device model and labeling; do not assume that a guidewire is MR Safe or MR Conditional without checking the manufacturer’s instructions.
• The guidewire is generally a single-use device and is not intended to remain implanted. Contraindications and warnings should be reviewed in the specific product labeling.