BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON

    MDR report key: 23403967 · Received October 28, 2025

    Report

    Report Number
    2124215-2025-75167
    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 BLADE FRACTURE AND PARTIAL DROPOUT OCCURRED. A PATIENT WAS UNDERWENT FOR RIGHT CORONARY ARTERY (RCA) PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR CHRONIC CORONARY SYNDROME. CARDIOVASCULAR AND RESPIRATORY PHYSICAL FINDINGS WERE NORMAL, AND NEUROLOGIC EXAMINATION REVEALED MILD LEFT HEMIPARESIS. IVUS WAS USED AND AS IT DID NOT PASS THROUGH THE LESION, ROTATIONAL ATHERECTOMY WAS PERFORMED USING A 1.25-MM BURR. IVUS AFTERWARD SHOWED A SHORT SEGMENT CIRCUMFERENTIAL SEVERE CALCIFICATION PROXIMAL TO THE TARGET LESION WITH A MLD OF 1.95 MM. ARTERIAL DIAMETER DISTAL TO THE CALCIFICATION WAS 3.12 MM. AFTER PERFORMING ORBITAL ATHERECTOMY OF THE CALCIFICATION, IT WAS DILATED USING A 2.5- 6-MM WOLVERINE CB, A DOG BONE-SHAPE WAS OBSERVED. THE CB WAS INFLATED IN A STEPWISE FASHION FROM 2 TO 12 ATMS IN INCREMENTS OF 2 ATMS. EIGHTEEN INFLATIONS WERE PERFORMED. AFTER A PROLONGED 45-S INFLATION AT 12 ATM, THE BALLOON INDENTATION ALMOST DISAPPEARED. THE CB CATHETER WAS PULLED OUT WITHOUT RESISTANCE. BLADE FRACTURE AND PARTIAL DROPOUT WERE OBSERVED. NO CORONARY PERFORATION OR SEVERE DISSECTION WAS SHOWN ON ANGIOGRAPHY. THE PATIENT SYMPTOMS RESOLVED, AND FOLLOW-UP CAG 6 MONTHS LATER SHOWED NO RESTENOSIS, NO RESIDUAL FRACTURED CB BLADE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619359 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