QUICKCLEAR THROMBECTOMY SYSTEM

Description of Event or Problem

ON (B)(6) 2025, A QUICK CLEAR DEVICE WAS USED IN A CLINICAL STUDY TO TREAT AN OCCLUSIVE DEEP VEIN THROMBOSIS (DVT) ON THE EXTERNAL ILIAC VEIN, COMMON FEMORAL VEIN, FEMORAL VEIN, AND NONOCCLUSIVE DVT LOCATED ABOVE THE KNEE IN THE POPLITEAL. HOWEVER, 2 DAYS POST INDEX PROCEDURE ON (B)(6) 2025, THE PATIENT EXPERIENCED LEFT INNER THIGH REDNESS AND PAIN WITH EXTREME PRESSURE WHILE WALKING. FOUR DAYS LATER ON (B)(6) 2025, A FOLLOW UP CALL REVEALED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED HEPARIN DRIP WITH NO OTHER INTERVENTION PERFORMED. IT WAS INDICATED THAT THIS IS POSSIBLY RELATED TO STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED REDNESS AND PAIN ON THE LEFT LEG, RESULTING IN HOSPITALIZATION AND INTERVENTION.

Additional Manufacturer Narrative

BLOCK A3B: THE PATIENT'S GENDER IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCK H3: THE QUICKCLEAR DEVICE WAS DISCARDED BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: PER THE IFU, ACCESS SITE INJURY, INCLUDING PAIN IS LISTED AS A POSSIBLE ADVERSE EVENT. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.