BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP BUTTON INITIAL PLACEMENT KIT

    MDR report key: 1203226 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05360
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED TWO DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE SCALPEL DIDN'T CUT WELL. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER DEVICE (UNKNOWN PRODUCT/MANUFACTURER). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON INITIAL PLACEMENT KIT KGC BOSTON SCIENTIFIC CORPORATION M00568510 11800811

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK