BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP BUTTON INITIAL PLACEMENT KIT

    MDR report key: 1143713 · Received August 29, 2008

    Report

    Report Number
    3005099803-2008-04214
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVAL CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 30, 2008, THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY DEVICE WAS PLACED ON SIX DAYS EARLIER. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS PLACED WITH 5MM MARGIN NOTED BETWEEN THE EXTERNAL BUMPER AND THE SKIN. IT WAS FURTHER REPORTED THAT ON FOUR DAYS PRIOR TO ORIGINAL DATE, "AN EFFUSION LEAK WAS IDENTIFIED BETWEEN THE BUTTON BODY AND THE HOLE"; NO INTERVENTION WAS TAKEN AT THIS TIME. ON TWO DAYS PRIOR TO ORIGINAL DATE, THE PT COMPLAINED OF ABDOMINAL PAIN. ACCORDING TO THE COMPLAINANT, WATER WAS INJECTED IN ATTEMPT TO ASPIRATE; THIS ATTEMPT WAS UNSUCCESSFUL. REPORTEDLY, A SUBSEQUENT ASSESSMENT OF THE DEVICE REALIZED THAT THE INTERNAL BUMPER OF THE DEVICE HAD DETACHED AND MIGRATED INTO THE ABDOMINAL CAVITY. IT WAS ALSO DETERMINED THAT THE PT HAD PERITONITIS. AT THAT TIME, THE TUBE WAS REMOVED. THE PATIENT'S CONDITION WAS REPORTED AS STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON INITIAL PLACEMENT KIT KGC BOSTON SCIENTIFIC CORPORATION M00568460 11767645

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other