BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON

    MDR report key: 23868086 · Received December 22, 2025

    Report

    Report Number
    2124215-2025-92391
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    January 1, 2019
    Report Date
    December 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: DATA WAS PROVIDED FOR EVENTS RECORDED JANUARY 2019 THROUGH DECEMBER 2024. 01JAN2019 SELECTED AS THE EARLIEST POSSIBLE DATE OF EVENT. DATA OBTAINED FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC AND NO FURTHER INFORMATION IS AVAILABLE. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE DATA ANALYSIS ON WOLVERINE USING THE PINC AI HEALTHCARE DATABASE FROM PREMIER. PATIENTS ARE IDENTIFIED THROUGH USE OF WOLVERINE AS IDENTIFIED IN CHARGE MASTER BILLING. ADVERSE EVENTS WERE IDENTIFIED THROUGH THE RESPECTIVE CPT/ICD-10 CODING. RATES ARE CALCULATED BY DIVIDING THE COUNT OF A CODE OVER THE TOTAL NUMBER OF WOLVERINE CLAIMS FOR THAT YEAR. THE PROCEDURES WERE PERFORMED FROM JANUARY 2019 THROUGH DECEMBER 2024. THESE ANALYSES ARE BEING PERFORMED AS A SPECIFIC ACTIVITY TO ASSESS SAFETY AND PERFORMANCE RATES ASSOCIATED WITH THE SUBJECT DEVICE. WOLVERINE OUTCOMES WERE ASSESSED AGAINST SIMILAR/BENCHMARK PRODUCTS. RATES OF THE ADVERSE EVENTS INCLUDING VESSEL TRAUMA/PERFORATION/DISSECTION, MYOCARDIAL INFARCTION (MI)/ISCHEMIA, INFECTION, CARDIAC TAMPONADE/PERICARDIAL EFFUSION, ACUTE RENAL FAILURE, ORGAN FAILURE/INSUFFICIENCY, ALLERGY, BLEEDING, HEMATOMA, HEMORRHAGE, EMBOLISM, RESPIRATORY FAILURE, STROKE, ARRHYTHMIA, SHOCK, THROMBOSIS, HEMODYNAMIC COMPROMISE AND ADDITIONAL INTERVENTION ARE REPORTED. A TOTAL OF 27095 PATIENTS UNDERWENT A PROCEDURE USING WOLVERINE. THE FOLLOWING IS A SUMMARY OF THOSE RESULTS OVER 5 YEARS (JANUARY 2019 THROUGH DECEMBER 2024): VESSEL TRAUMA/PERFORATION/DISSECTION RATES FOR WOLVERINE CASES: 346 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 1.28%, COMPARED TO THE COMPETITOR RATE OF 0.88%-1.12%. VESSEL TRAUMA/PERFORATION/DISSECTION RATE FOR WOLVERINE CLAIMS IS HIGHER THAN THAT OF THE SIMILAR/BENCHMARK PRODUCTS IN THE ANALYSIS, HOWEVER THE CONFIDENCE INTERVALS OVERLAP. THE RATES ARE SIMILAR; THEREFORE, THE SAFETY GOALS WERE MET. MYOCARDIAL INFARCTION RATES FOR WOLVERINE CASES: 136 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.50%, COMPARED TO THE COMPETITOR RATE OF 0.19%-0.31%. MYOCARDIAL INFARCTION RATE FOR WOLVERINE CLAIMS IS HIGHER THAN THAT OF THE SIMILAR/BENCHMARK PRODUCTS IN THE ANALYSIS, HOWEVER THE CONFIDENCE INTERVALS OVERLAP. THE RATES ARE SIMILAR; THEREFORE, THE SAFETY GOALS WERE MET. MYOCARDIAL INFARCTION/ISCHEMIA RATES FOR WOLVERINE CASES: 165 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.61%, COMPARED TO THE COMPETITOR RATE OF 0.25%-0.45%. MYOCARDIAL INFARCTION/ISCHEMIA RATE FOR WOLVERINE IS HIGHER THAN THAT OF THE SIMILAR/BENCHMARK PRODUCTS IN THE ANALYSIS, HOWEVER THE CONFIDENCE INTERVALS OVERLAP, THEREFORE THE RATE IS SIMILAR TO THOSE OF SIMILAR/BENCHMARK DEVICES. RATES FOR MI/ISCHEMIA ARE COMPARABLE TO THOSE OF SIMILAR/BENCHMARK DEVICES AND ARE THEREFORE ACCEPTABLE. INFECTION RATES FOR WOLVERINE CASES: 157 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.58%, COMPARED TO THE COMPETITOR RATE OF 0.67%-0.82%. INFECTION RATE FOR WOLVERINE CLAIMS IS LOWER THAN THOSE OF SIMILAR/BENCHMARK DEVICES. THE RATE FOR INFECTION IS COMPARABLE TO THOSE OF THE SIMILAR/BENCHMARK PRODUCTS AND IS THEREFORE ACCEPTABLE. CARDIAC TAMPONADE/PERICARDIAL EFFUSION RATE FOR WOLVERINE CASES: 110 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.41%, COMPARED TO THE COMPETITOR RATE OF 0.27%-0.31%. CARDIAC TAMPONADE / PERICARDIAL EFFUSION OCCURRING IN THE SETTING OF A PCI WOULD LIKELY BE CAUSED BY VESSEL TRAUMA. CARDIAC TAMPONADE/PERICARDIAL EFFUSION RATE FOR WOLVERINE CLAIMS IS HIGHER THAN THAT OF THE SIMILAR/BENCHMARK PRODUCTS IN THE ANALYSIS, HOWEVER THE CONFIDENCE INTERVALS OVERLAP, THEREFORE THE RATE IS SIMILAR TO THOSE OF SIMILAR/BENCHMARK DEVICES. RATES FOR CARDIAC TAMPONADE / PERICARDIAL EFFUSION ARE COMPARABLE TO THOSE OF THE SIMILAR/BENCHMARK PRODUCTS AND ARE THEREFORE ACCEPTABLE. ACUTE RENAL FAILURE RATES WOLVERINE CASES: 697 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 2.57%, COMPARED TO THE COMPETITOR RATE OF 2.47%-2.67%. THE ACUTE RENAL FAILURE RATE FOR WOLVERINE CUTTING BALLOON FALLS WITHIN THE RANGE OF THE SIMILAR/BENCHMARK DEVICES. THE RATE FOR ORGAN FAILURE IS COMPARABLE TO THOSE OF THE SIMILAR/BENCHMARK PRODUCTS AND IS THEREFORE ACCEPTABLE. ORGAN FAILURE RATES FOR WOLVERINE CASES: 1186 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 4.38%, COMPARED TO THE COMPETITOR RATE OF 4.28%-4.60%. THE ORGAN FAILURE RATE FOR WOLVERINE CUTTING BALLOON FALLS WITHIN THE RANGE OF THE SIMILAR/BENCHMARK DEVICES. THE RATE FOR ORGAN FAILURE IS COMPARABLE TO THOSE OF THE SIMILAR/BENCHMARK PRODUCTS AND IS THEREFORE ACCEPTABLE. ORGAN INSUFFICIENCY RATES FOR WOLVERINE CASES: 133 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.49%, COMPARED TO THE COMPETITOR RATE OF 0.33%-0.40%. THE ORGAN INSUFFICIENCY RATE FOR WOLVERINE CUTTING BALLOON IS HIGHER THAN THAT OF THE RANGE OF SIMILAR/BENCHMARK DEVICES, HOWEVER THE RATE IS ACCEPTABLE AS THE LCI FALLS WITHIN THE UCI OF SIMILAR BENCHMARK DEVICES. THE RATE FOR ORGAN INSUFFICIENCY IS COMPARABLE TO THOSE OF SIMILAR/BENCHMARK DEVICES AND IS THEREFORE ACCEPTABLE. ALLERGY RATES FOR WOVLERINE CASES: 91 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.34%, COMPARED TO THE COMPETITOR RATE OF 0.03%-0.49%. ALLERGY RATES FOR WOLVERINE CUTTING BALLOON FALL WITHIN THE RANGE OF THE SIMILAR/BENCHMARK DEVICES. RATES FOR ALLERGY ARE COMPARABLE TO THOSE OF THE SIMILAR/BENCHMARK PRODUCTS AND ARE THEREFORE ACCEPTABLE. BLEEDING RATES FOR WOLVERINE CASES: 862 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 3.18%, COMPARED TO THE COMPETITOR RATE OF 3.48%-3.64%. THE BLEEDING RATE FOR WOLVERINE CUTTING BALLOON IS LOWER THAN THAT OF THE RANGE OF SIMILAR/BENCHMARK DEVICES. THE RATE FOR BLEEDING IS THEREFORE ACCEPTABLE. HEMATOMA RATES FOR WOLVERINE CASES: 150 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.55%, COMPARED TO THE COMPETITOR RATE OF 0.34%-0.49%. THE HEMATOMA RATE FOR WOLVERINE CUTTING BALLOON IS HIGHER THAN THAT OF THE RANGE OF SIMILAR/BENCHMARK DEVICES, HOWEVER THE RATE IS ACCEPTABLE AS THE LCI FALLS WITHIN THE UCI OF SIMILAR BENCHMARK DEVICES. THE RATE FOR HEMATOMA IS COMPARABLE TO THOSE OF SIMILAR/BENCHMARK DEVICES AND IS THEREFORE ACCEPTABLE. HEMORRHAGE RATES FOR WOLVERINE CASES: 591 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 2.18%, COMPARED TO THE COMPETITOR RATE OF 2.71%-2.75%. THE HEMORRHAGE RATE FOR WOLVERINE CUTTING BALLOON IS LOWER THAN THE RANGE OF SIMILAR/BENCHMARK DEVICES. THE RATE FOR HEMORRHAGE IS THEREFORE ACCEPTABLE. EMBOLISM RATES FOR WOLVERINE CASES: 220 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.81%, COMPARED TO THE COMPETITOR RATE OF 0.68%-1.29%. THE EMBOLISM RATE FOR THE WOLVERINE CUTTING BALLOON FALLS WITHIN THE RANGE OF SIMILAR/BENCHMARK DEVICES. THE RATE FOR EMBOLISM IS COMPARABLE TO THE SIMILAR/BENCHMARK DEVICE RATES AND IS THEREFORE ACCEPTABLE. RESPIRATORY FAILURE RATES FOR WOLVERINE CASES: 162 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.60%, COMPARED TO THE COMPETITOR RATE OF 0.56%-0.69%. THE RESPIRATORY FAILURE RATE FOR THE WOLVERINE CUTTING BALLOON FALLS WITHIN THE RANGE OF SIMILAR/BENCHMARK DEVICES. THE RATE PRESENTED IS COMPARABLE TO THE SIMILAR/BENCHMARK DEVICE RATES AND IS THEREFORE ACCEPTABLE. STROKE RATES FOR WOLVERINE CASES: 154 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.57%, COMPARED TO THE COMPETITOR RATE OF 0.63%-0.68%. THE STROKE RATE FOR THE WOLVERINE CUTTING BALLOON IS LOWER THAN THE RANGE OF BSC SIMILAR/BENCHMARK DEVICES. THE RATE PRESENTED IS LOWER THAN THE SIMILAR/BENCHMARK DEVICE RATES AND IS THEREFORE ACCEPTABLE. ARRHYTHMIA RATES FOR WOLVERINE CASES: 1676 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 6.19%, COMPARED TO THE COMPETITOR RATE OF 5.44%-6.73%. THE ARRHYTHMIA RATE FOR THE WOLVERINE CUTTING BALLOON FALLS WITHIN THE RANGE OF THE SIMILAR/BENCHMARK DEVICES. ALTHOUGH RATES ARE HIGH, THEY ARE REPRESENTATIVE OF THE PCI PROCEDURES THEY ARE OCCURRING IN AND ARE NOT LIKELY TO BE CAUSED BY THE CUTTING BALLOON. THE RATES PRESENTED ARE COMPARABLE TO THE SIMILAR/BENCHMARK DEVICE RATES AND ARE THEREFORE ACCEPTABLE. SHOCK RATES FOR WOLVERINE CASES: 1160 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 4.28%, COMPARED TO THE COMPETITOR RATE OF 3.47%-4.79%. THE SHOCK RATE FOR THE WOLVERINE CUTTING BALLOON FALLS WITHIN THE RANGE OF THE SIMILAR/BENCHMARK DEVICES. WHILE CUTTING BALLOONS THEMSELVES DO NOT DIRECTLY CAUSE SHOCK, THESE EVENTS MAY RESULT SECONDARILY FROM VESSEL TRAUMA OR PERFORATION, WHICH CAN LEAD TO PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. HOWEVER, THE INCIDENCE OF VESSEL TRAUMA, PERICARDIAL EFFUSION, AND TAMPONADE WAS NOT ELEVATED, MAKING THIS PATHWAY, AND THUS A CAUSAL LINK BETWEEN THE DEVICE AND SHOCK, UNLIKELY. THROMBOSIS RATES FOR WOLVERINE CASES: 71 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.26%, COMPARED TO THE COMPETITOR RATE OF 0.27%-0.38%. THE THROMBOSIS RATE FOR THE WOLVERINE CUTTING BALLOON IS LOWER THAN THE RANGE OF THE SIMILAR/BENCHMARK DEVICES. THE RATE FOR THROMBOSIS IS COMPARABLE TO THE SIMILAR/BENCHMARK DEVICE RATES AND IS THEREFORE ACCEPTABLE. HEMODYNAMIC COMPROMISE RATES FOR WOLVERINE CASES: 1218 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 4.50%, COMPARED TO THE COMPETITOR RATE OF 3.78%-4.98%. THE HEMODYNAMIC COMPROMISE RATE FOR THE WOLVERINE CUTTING BALLOON FALLS WITHIN THE RANGE OF THE SIMILAR/BENCHMARK DEVICES. THE RATE FOR HEMODYNAMIC COMPROMISE IS COMPARABLE TO THE SIMILAR/BENCHMARK DEVICE RATES AND IS THEREFORE ACCEPTABLE. ADDITIONAL INTERVENTION RATES FOR WOLVERINE CASES: 245 OUT OF 27095 PATIENTS RESULTING IN A RATE OF 0.90%, COMPARED TO THE COMPETITOR RATE OF 0.59%-0.88%. ADDITIONAL INTERVENTION RATE FOR WOLVERINE CUTTING BALLOON IS NUMERICALLY HIGHER THAN THE OTHER SIMILAR/BENCHMARK DEVICES BEING ANALYZED, HOWEVER THE RATES ARE ACCEPTABLE AS THE LCI FALLS WITHIN THE UCI OF SIMILAR BENCHMARK DEVICES. THE RATE FOR ADDITIONAL INTERVENTION IS COMPARABLE TO THOSE OF SIMILAR/BENCHMARK DEVICES AND IS THEREFORE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563791 WOLVERINE CORONARY CUTTING BALLOON CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O