BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY

    MDR report key: 1238987 · Received November 20, 2008

    Report

    Report Number
    3005099803-2008-06640
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Adverse Event
    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 CORP THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT COULD NOT BE USED DUE TO A GAP BETWEEN THE PT'S STOMACH WALL AND ABDOMINAL WALL (PT AGE, GENDER AND WEIGHT ARE UNK). ACCORDING TO THE COMPLAINANT, AT THE LOCATION OF THE CATHETER PARTIALLY EXITING A 5 MILLIMETER ABDOMINAL INCISION, A 10 MILLIMETER BY 10 MILLIMETER CROSS CUT INCISION WAS MADE. WHEN THE DEVICE WAS PULLED, THE BUTTON COMPLETELY PULLED OUT. THE STOMACH WALL WAS CLIPPED AND THE PROCEDURE CANCELLED DUE TO THIS EVENT. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KGC BOSTON SCIENTIFIC CORPORATION M00568520 11942738

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other