BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON

    MDR report key: 1191928 · Received October 1, 2008

    Report

    Report Number
    3005099803-2008-04957
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GCA
    PMA / PMN Number
    K931619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE BALLOON FAILED TO INFLATE. THE TARGET LESIONS WERE GALLSTONES LOCATED IN THE BILE DUCT. AN EXTRACTOR XL 8.5 MM BALLOON HAD BEEN SELECTED TO SWEEP OUT THE GALLSTONES. WHILE PREPARING THE DEVICE, IT WAS NOTICED THAT THE BALLOON WOULD NOT INFLATE. THE DEVICE DID NOT COME INTO CONTACT WITH THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR XL TRIPLE LUMEN RETRIEVAL BALLOON GCA BOSTON SCIENTIFIC M00550450 11787740

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR