BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL

    MDR report key: 1833361 · Received September 8, 2010

    Report

    Report Number
    MW5017382
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 7, 2010
    Manufacturer
    COOK MEDICAL INC.
    Product Code
    GCA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ERCP WAS IN PROGRESS, COMMON BILE DUCT STONE WAS EXTRACTED, COMMON BILE DUCT WAS SWEPT WITH BALLOON AGAIN AND IT FAILED TO INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MEDICAL FUSION QUATTRO EXTRACTION BALLOON GCA COOK MEDICAL INC. W2889581

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other