BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK

    MDR report key: 5384933 · Received January 22, 2016

    Report

    Report Number
    5384933
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    September 25, 2015
    Report Date
    December 11, 2015
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MAV 2 BALOON RUPTURED DURING A PCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45383 MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 17971396

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR