BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON

    MDR report key: 23403980 · Received October 28, 2025

    Report

    Report Number
    2124215-2025-75250
    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 WOLVERINE CB BECAME STUCK AND A BLADE FRACTURE OCCURRED. A CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED AND SHOWED OCCLUDED LEFT ANTERIOR DESCENDING ARTERY (LAD), AND STENOTIC RIGHT CORONARY ARTERY (RCA) WITH LARGE, CALCIFIED LESION ON A PATIENT, HE WAS DIAGNOSED WITH CHRONIC CORONARY SYNDROME. A ROTATIONAL ATHERECTOMY WAS PERFORMED USING A .5 MM BURR. IVUS AFTERWARD SHOWED SEVERE STENOSIS OWING TO A LARGE, CALCIFIED NODULE; WIRE BIAS WAS NOT TOWARD THE LESION. A 2.5-10 MM WOLVERINE CB WAS INFLATED IN THE LESION IN A STEPWISE FASHION FROM 2-6 ATM IN 2 ATM INCREMENTS FOR 10-15 S AT EACH PRESSURE WHILE MOVING BACK AND FORTH. TEN INFLATIONS WERE PERFORMED. THE CB BECAME TEMPORARILY STUCK IN THE LESION AND SIGNIFICANT RESISTANCE WAS EXPERIENCED WHILE WITH DRAWING IT. VISUAL OBSERVATION OF THE CB CONFIRMED BLADE FRACTURE. NO CORONARY PERFORATION OR SEVERE DISSECTION WAS OBSERVED ON ANGIOGRAPHY OR IVUS. THE PATIENT WAS DISCHARGED. AT THE TIME OF PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE LAD 3MONTHS LATER, THERE WAS NO RESTENOSIS AT THE PCI SITE OF THE RCA, MONTHS LATER RCA RESTENOSIS WAS OBSERVED, A 4.0 -24 MMD RUG-ELUTING STENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045883 WOLVERINE CORONARY CUTTING BALLOON CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male