Tracker-25 Infusion Catheter

FDA-Cleared Indications

• Percutaneous catheterization of blood vessels for diagnostic or therapeutic procedures.
• Delivery of fluids or medications through the vascular system when clinically indicated.

Clinical Applications

• Percutaneous vascular access during image-guided endovascular procedures.
• Infusion of medications or fluids into an accessed blood vessel.
• Catheter-based treatment procedures in which a small-caliber infusion catheter is required.

Reported off-label uses

• Selective catheter-directed thrombolysis or infusion during treatment of venous thromboembolism, when the treating physician determines that use is appropriate.
• Infusion during selected venous interventions, including some thrombectomy or venous-stenting procedures, when compatible with the catheter's labeling and specifications.

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 catheter's French size, length, lumen configuration, guidewire compatibility, and maximum injection pressure before use.
• Use sterile technique and fluoroscopic or other appropriate imaging guidance for vascular placement.
• Inspect the catheter before use for damage, kinking, or obstruction, and follow the manufacturer's instructions for flushing and infusion.
• MRI safety, including whether the catheter is MR Safe, MR Conditional, or MR Unsafe, should be confirmed from the current product labeling; the FDA record alone does not establish MRI status.
• Potential risks include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, catheter fracture, and contrast-related complications.