BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL 3.5X12

    MDR report key: 1983467 · Received February 1, 2011

    Report

    Report Number
    1983467
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON WAS INSERTED ALONG GUIDEWIRE BUT BALLOON WAS UNABLE TO ADVANCE OVER THE WIRE. PHYSICIAN FEELS THAT WIRE WAS DEFECTIVE, TOO THICK TO THREAD THE BALLOON.====================== MANUFACTURER RESPONSE FOR CARDIAC CATH BALLOON, APEX MONORAIL 3.5X12: THEY ARE INVESTIGATING.====================== MANUFACTURER RESPONSE FOR GUIDEWIRE, BMW 190CM GUIDEWIRE: THEY ARE INVESTIGATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL 3.5X12 CATHETER, TRANSLUMINAL, CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC * 13967846
    2 BMW GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR