BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON MONORAIL

    MDR report key: 17030759 · Received May 31, 2023

    Report

    Report Number
    2124215-2023-27282
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 22, 2023
    Report Date
    May 31, 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 A BALLOON RUPTURE OCCURRED. ON AN UNSPECIFIED DATE, AN UNKNOWN STENT WAS IMPLANTED. IN (B)(6) 2023, 50% IN-STENT RESTENOSIS WAS NOTED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 10MMX2.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 4 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. AS PER PHYSICIAN, POOR SPREAD OF ISR STENT AND STRUT WAS THOUGHT TO BE THE CAUSE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131827 WOLVERINE CORONARY CUTTING BALLOON MONORAIL CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION 3851 0031072947

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown