BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON

    MDR report key: 22779633 · Received August 11, 2025

    Report

    Report Number
    2124215-2025-56009
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: ESTIMATED BASED ON AWARE DATE. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT 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 THAT DISSECTION OCCURRED. INFORMATION WAS OBTAINED AT THE 33RD JAPANESE SOCIETY OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS IN 2025. PERCUTANEOUS CORONARY INTERVENTION (PCI) USING DRUG-COATED BALLOON (DCB) IS TREATMENT THAT HAS THE BENEFIT OF NOT USING STENTS. IT IS IMPORTANT NOT TO CREATE SERIOUS CORONARY DISSECTION WITH PRE-DILATION. WE HYPOTHESIZED THAT STEPWISE CUTTING BALLOON (CB) EXPANSION MAKE LARGE DILATION WITH LESS STRESSING THE INTIMA. AMONG 126 CONSECUTIVE PATIENTS WHO UNDERWENT PCI USING THE WOLVERINE? CUTTING BALLOON (CB) AT OUR INSTITUTION BETWEEN JANUARY 2023 AND JUNE 2024, 88 CONSECUTIVE PATIENTS WERE INCLUDED AFTER EXCLUSION OF IN-STENT STENOSIS AND USE OF DEBULKING DEVICES OR INTRAVASCULAR LITHOTRIPSY. PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE STEPWISE EXPANSION OF CB: STEPWISE GROUP (N = 47) AND NON-STEPWISE GROUP (N = 41). WE COMPARED PATIENT BACKGROUND, CHARACTERISTICS OF LESION AND PCI PROCEDURE BETWEEN THE TWO GROUPS. THE STEPWISE GROUP HAD LESS INCIDENCE OF PREVIOUS PCI THAN THE NON-STEPWISE GROUP. THERE WAS NO DIFFERENCE IN LESION CHARACTERISTICS. ALTHOUGH THE STEPWISE GROUP USED LARGER CB, THERE WAS LESS DISSECTION AFTER DILATION. THERE WAS NO DIFFERENCE IN FINAL DEVICES. THE STEPWISE GROUP USING DCB AS FINAL DEVICE HAD SMALLER STENOSIS AND LARGER MINIMAL LUMINAL DIAMETER. THERE WAS NO DIFFERENCE BETWEEN THE TWO GROUPS WHEN DES WAS USED. HOWEVER, INCIDENCE OF RESTENOSIS DOES NOT DIFFER IN THESE TWO GROUPS. STEPWISE CB DILATION MAY BE USEFUL WHEN DCB IS USED AS THE FINAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271040 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 Other