BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONORAIL MAVERICK 2

    MDR report key: 1010236 · Received March 10, 2008

    Report

    Report Number
    MW5005830
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 11, 2008
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BALLOON WAS INSERTED TO THE CIRCUMFLEX CORONARY ARTERY. THE BALLOON DID NOT INFLATE WHEN ATTEMPTED LEADING US TO BELIEVE THAT THE BALLOON WAS DAMAGED. WHEN TRYING TO REMOVE THE BALLOON, ONLY THE PROXIMAL HALF OF THE BALLOON SHAFT CAME OUT. THE DISTAL HALF OF THE BALLOON WAS STILL IN THE ARTERY WITH THE BALLOON STILL AT THE LESION. WHEN ATTEMPTED TO REMOVE BY REMOVING THE PTCA WIRE, THE PROXIMAL HALF OF THE BALLOON CAME OUT WITH THE WIRE THROUGH THE GUIDING CATHETER. THIS WAS FOLLOWED ALL OF THE WAY OUT OF THE BODY UNDER FLUOROSCOPY. ALL EQUIPMENT WAS SUCCESSFULLY REMOVED FROM THE BODY. NO ADVERSE EVENTS HAPPENED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONORAIL MAVERICK 2 BALLOON 2.25X20MM LOX 8299841

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR