BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ALLSCOPE SPHINCTEROTOME

    MDR report key: 1074583 · Received July 11, 2008

    Report

    Report Number
    3005099803-2008-01129
    Event Type
    Death
    Date Received
    July 11, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K970053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE WILL NOT BE RETURNED; THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED. THE MAY 2008 15-MONTH RX SPHINCTEROTOME PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A RX ALLSCOPE SPHINCTEROTOME DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ABOUT 2 DAYS PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PT DESATURATED, STOPPED BREATHING AND DIED. THE COMPLAINANT INFORMED A BSC SALES REP THAT THE PT WAS IN POOR CONDITION PRIOR TO THE PROCEDURE. THE CAUSE OF DEATH HAS NOT BEEN ASCERTAINABLE FROM THE COMPLAINANT; NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ALLSCOPE SPHINCTEROTOME KNS BOSTON SCIENTIFIC CORPORATION M00545050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death