BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1181514 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04820
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #3005099803-2008-04827. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, THE SPHINCTEROTOME WOULD NOT BOW AND A SHAFT KINK OCCURRED ON THE BALLOON. THE LESION WAS LOCATED IN AN UNSPECIFIED BILIARY DUCT. THE JAGTOME RX SPHINCTEROTOME WAS ADVANCED TO AN UNSPECIFIED LOCATION, HOWEVER, UPON ATTEMPTING TO PERFORM A SPHINCTEROTOMY, THE DEVICE WAS UNABLE TO "BOW". THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED. AT AN UNSPECIFIED TIME LATER, THE SHAFT OF THE EXTRACTOR RX 12MM X 15MM RETRIEVAL BALLOON KINKED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546910 0011882332

    Patients

    Seq Age Sex Outcome Treatment
    1