QUICKCLEAR THROMBECTOMY SYSTEM

Description of Event or Problem

ON (B)(6) 2023, A QUICKCLEAR DEVICE WAS USED IN A CLINICAL STUDY TO TREAT AN OCCLUSIVE DEEP VEIN THROMBOSIS (DVT) ON THE COMMON ILIAC VEIN, EXTERNAL ILIAC VEIN, COMMON FEMORAL VEIN, FEMORAL VEIN, AND A NONOCCLUSIVE DVT IN THE FEMORAL VEIN. AFTER TREATMENT, THE PATIENT WAS SENT HOME; HOWEVER, THE PATIENT EXPERIENCED SYNCOPAL EPISODE AND REQUIRED EMERGENCY CARE. THE PATIENT WAS ANEMIC WHEN SHE ARRIVED IN THE EMERGENCY ROOM (ER), THUS ADMINISTERED WITH 1 UNIT OF BLOOD AND IV FLUIDS. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY. IT WAS THOUGHT THAT THE MOST LIKELY CAUSE FOR THE SYNCOPE EPISODE, WAS DUE TO HYPOVOLEMIA AND BLOOD LOSS ANEMIA POST INDEX PROCEDURE. THIS WAS DETERMINED TO BE DEFINITELY RELATED TO THE STUDY PROCEDURE AND POSSIBLY RELATED TO THE QUICKCLEAR DEVICE. ON (B)(6) 2023, THE PATIENT EXPERIENCED ANOTHER SYNCOPAL EPISODE AND RETURNED TO THE ER FOR TREATMENT. A CT SCAN SHOWED "FLUID COLLECTION WITHIN SEMI MEMBRANOUS MUSCLE BELLY AND INCLUDING THE ADDUCTOR MUSCLE GROUPS LIKELY CONSISTENT WITH AN AGE-INDETERMINATE HEMATOMA WITHOUT EVIDENCE OF ACTIVE EXTRAVASATION". THE PATIENT WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) TO TREAT ANEMIA WHICH WAS THOUGHT TO BE FROM THE SPONTANEOUS HEMATOMA. HER ASPIRIN AND LOVENOX (ENOXAPARIN) WERE STOPPED AND STARTED ON A HEPARIN DRIP. A DAILY ACE WRAP WAS PROVIDED FROM LEFT FOOT TO LEFT PROXIMAL THIGH FOR HEMATOMA TAMPONADE. A FEW DAYS LATER, ON (B)(6) 2023, THE PATIENT'S HEMOGLOBIN DROPPED AGAIN, AND RECEIVED 2 MORE UNITS OF PRBC. THE HEPARIN DRIP WAS STOPPED AND A NEW IVC FILTER WAS PLACED. FIVE DAYS LATER ON (B)(6) 2023, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. THIS ADVERSE EVENT WAS DETERMINED AS NOT RELATED TO THE STUDY PROCEDURE OR THE QUICKCLEAR DEVICE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE PATIENT EXPERIENCED SYNCOPAL EPISODE, RESULTING IN HOSPITALIZATION AND INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE QUICKCLEAR DEVICE.

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, BLEEDING COMPLICATIONS WHICH MAY REQUIRE TRANSFUSION AND HEMATOMA ARE 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.