BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLVERINE CORONARY CUTTING BALLOON MONORAIL

    MDR report key: 10779446 · Received November 3, 2020

    Report

    Report Number
    2134265-2020-15225
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 24, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NWX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER CITY: (B)(6). MIE PREFECTURE 5108561.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 10MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, AFTER PASSING THROUGH THE LESION, THE BALLOON RUPTURED WHEN APPLYING PRESSURE AT 4ATM AT FIRST INFLATION. PHYSICIAN SAID THAT IT SEEMS THAT THE BALLOON GOT DAMAGED BY THE CALCIFICATION. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244233 WOLVERINE CORONARY CUTTING BALLOON MONORAIL CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING NWX BOSTON SCIENTIFIC CORPORATION 3851 0025878339

    Patients

    Seq Age Sex Outcome Treatment
    1