BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1055514 · Received June 2, 2008

    Report

    Report Number
    MW5007118
    Event Type
    Other
    Date Received
    June 2, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING ERCP PROCEDURE FOR REMOVAL OF GALLSTONES. PT STATUS POST CHOLECYSTECTOMY 7 DAYS AGO. AT 20 WEEKS GESTATION. DR. PERFORMING PROCEDURE OF STONE REMOVAL, REMOVES TWO LARGE STONES AND ATTEMPTS TO REMOVE THE THIRD AND AS HE ADVANCES THE BASKET THE METAL TIP ON THE END OF THE BASKET BREAKS. DR INSERTS PLASTIC BILIARY STENT AT THIS TIME FOR THE DUCT TO REMAIN PATENT AND DRAINING, DESIRING THAT THE METAL TIP WILL DRAIN OUT. WILL REMAIN ACTIVE IN CARE OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC TRAPEZOID BASKET FFL BOSTON SCIENTIFIC REF M0051088 11289956

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other