BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1111548 · Received August 13, 2008

    Report

    Report Number
    3005099803-2008-02186
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY PROCEDURE (ERCP), A BALLOON BREAK AND DETACHMENT OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED "BILIARY DUCT". THE EXTRACTOR RX 12MM X 15MM RETRIEVAL BALLOON WAS ADVANCED, HOWEVER, AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE "BALLOON BROKE AND DISENGAGED FROM THE CATHETER IN THE PATIENT'S AMPILLA". THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED BALLOON WITH A SNARE DEVICE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention