BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME

    MDR report key: 1792005 · Received August 2, 2010

    Report

    Report Number
    1792005
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE PROTECTIVE SHEATH THAT COVERS THE CUTTING BALLOON WOULD NOT COME OFF. HAD TO PULL SO HARD THE CATHETER WAS STRETCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC * EK5241

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR