BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON MONORAIL

    MDR report key: 17453712 · Received August 3, 2023

    Report

    Report Number
    2124215-2023-41358
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. ON AN UNSPECIFIED DATE, AN UNKNOWN STENT WAS IMPLANTED. IN JULY 2023, 50% IN-STENT RESTENOSIS WAS NOTED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A 15MMX2.50MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED ONCE AT 8 ATMOSPHERES THEN RUPTURED UPON SECOND INFLATION AT 7 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. AS PER PHYSICIAN, THE STENT STRUTS MAY HAVE GONE BAD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279387 WOLVERINE CORONARY CUTTING BALLOON MONORAIL CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION 3852 0031105442

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown