BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 2561454 · Received May 2, 2012

    Report

    Report Number
    MW5025263
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 26, 2012
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIAC BALLOON FAILED TO DEFLATE AFTER INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT ABBOTT VASCULAR BALLOON LIT ABBOTT VASCULAR 5.00MM X 15MM 143CM 1102861

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR