BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1191930 · Received October 1, 2008

    Report

    Report Number
    3005099803-2008-04952
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP), INFLATION DIFFICULTIES WERE ENCOUNTERED. WHILE TRYING TO INFLATE THE EXTRACTOR RX RETRIEVAL BALLOON IN THE COMMON BILE DUCT, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR RX BALLOON. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC CORK LTD. M00546910 11450084

    Patients

    Seq Age Sex Outcome Treatment
    1