BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON

    MDR report key: 23403969 · Received October 28, 2025

    Report

    Report Number
    2124215-2025-75139
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    June 18, 2025
    Report Date
    October 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DAI KAWAUCHI, MD, KEI YUNOKI, MD, PHD, TOMOHIRO YOSHINO, MD, TAKEFUMI OKA, MD, PHD. CUTTING BALLOON BLADE FRACTURE IN SEVERE CALCIFIED LESIONS DURING PERCUTANEOUS CORONARY INTERVENTION 2025, VOL. 30, NO. 15 HTTPS://DOI/10.1016/J.JACCAS.2025.103773. B3 DATE OF EVENT: USED THE DATE THAT THE JOURNAL ARTICLE WAS PUBLISHED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE LOT NUMBER IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT A BALLOON WAS POORLY DILATED, AND A DOG-BONE SHAPE WAS OBSERVED, AND A BLADE FRACTURE OCCURRED. AN AVF. TRANSTHORACIC ECHO CARDIOGRAPHY REVEALED A MILD WALL MOTION ABNORMALITY IN THE INFERIOR LEFT VENTRICLE. HIGH-SENSITIVITY CARDIAC TROPONIN T CONCENTRATION WAS 2.290 NG ML (NORMAL, 0.014 NG ML). NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION WAS DIAGNOSED, AND EMERGENCY CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED, WHICH SHOWED DISTAL TOTAL OCCLUSION OF THE RIGHT CORONARY ARTERY (RCA) AND SIGNIFICANT STENOSIS OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE RCA OCCLUSION WAS PREDILATED USING A 2.0 COMPLIANT BALLOON, WHICH RESTORED FLOW; HOWEVER, BALLOON INDENTATION REMAINED. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED SHORT LENGTH-CIRCUMFERENTIAL CALCIFICATION WITHIN THE CULPRIT LESION, WHICH HAD A MINIMUM LUMEN DIAMETER (MLD) OF 1.75 MM. THE ARTERIAL DIAMETER DISTAL TO THE LESION WAS 3.25 MM. A 2.75- 6-MM WOLVERINE CB WAS INFLATED IN A STEPWISE FASHION FROM 2-18 ATM IN 2-ATM INCREMENTS, HOLDING EACH PRESSURE FOR 10 TO 15 SECONDS. EIGHTEEN INFLATIONS WERE PERFORMED. THE CUTTING BALLOON WAS POORLY DILATED, AND A DOG-BONE SHAPE WAS OBSERVED; HOWEVER, THE INDENTATION DISAPPEARED AFTER A PROLONGED INFLATION AT 18ATM FOR 60 S. SIGNIFICANT RESISTANCE WAS EXPERIENCED WHILE PULLING THE CB. VISUAL OBSERVATION OF THE CB CONFIRMED BLADE FRACTURE. NO CORONARY PERFORATION OR SEVERE DISSECTION WAS SHOWN ON ANGIOGRAPHY. PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 14. ONE YEAR FOLLOW-UP CAG SHOWED NO RESTENOSIS AT THE PCI SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619361 WOLVERINE CORONARY CUTTING BALLOON CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male