AngioJet Ultra Avx Thrombectomy Set Model 105039

FDA-Cleared Indications

• Removal of thrombus from the venous system.
• Mechanical thrombectomy in patients with venous thrombotic occlusion when removal of clot is clinically indicated.

Clinical Applications

• Image-guided mechanical thrombectomy for selected deep vein thrombosis.
• Removal of venous thrombus to restore or improve venous blood flow.
• Treatment of thrombotic occlusion in a venous segment when catheter-based clot removal is selected.
• Use by trained clinicians in hospital or specialized vascular procedure settings.

Reported off-label uses

• Use in pulmonary embolism thrombectomy has been reported for AngioJet-type thrombectomy systems, but this should not be assumed to be covered by the specific venous indication for model 105039.
• Use in thrombosed dialysis grafts or fistulas has been described for AngioJet-type systems, but the specific indication and device compatibility must be confirmed before use.

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 device is used with an AngioJet console, saline, aspiration, and fluoroscopic or other appropriate imaging guidance by trained clinicians.
• Catheter size, treatment length, clot burden, vessel diameter, and access route must be matched to the patient and the device instructions for use.
• The FDA record identifies this as a Class II device cleared through the 510(k) pathway under product code QEZ; the current manufacturer instructions should be reviewed because product configurations and labeling can change.
• MRI safety should not be assumed from the 510(k) record. The set is generally used during an interventional procedure and should be removed before MRI unless current labeling specifically identifies the device or retained components as MR safe or MR conditional.
• Potential complications include bleeding, vascular injury, distal embolization, hemolysis, kidney injury, infection, arrhythmia, and complications related to contrast, anticoagulation, sedation, or vascular access.