BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON MONORAIL

    MDR report key: 14920133 · Received July 5, 2022

    Report

    Report Number
    2134265-2022-07630
    Event Type
    Malfunction
    Date Received
    July 5, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 5, 2022
    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

    INITIAL REPORTER CITY: MIYAZAKI CITY MIYAZAKI PREF. 8800834.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 10MMX3.25MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423568 WOLVERINE CORONARY CUTTING BALLOON MONORAIL CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION 3851 0029186555

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown