BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1171164 · Received September 22, 2008

    Report

    Report Number
    3005099803-2008-04764
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K971906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MFR DATE IS UNKNOWN. ALTHOUGH, THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVAL, IT HAS NOT BEEN REC'D. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 08/25/08 THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED FOR A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE, (PLACEMENT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE RIGHT ANGLE TUBE WAS BROKEN AND THE DISTAL PART FELL INTO THE BUTTON SHAFT, (NOT INTO THE STOMACH) THREE MONTHS AFTER PLACEMENT (2008). THE DETACHED PORTION WAS REMOVED WITH KOCHER FORCEPS. THE DEVICE WAS REPLACED WITH A SECOND BUTTON REPLACEMENT GASTROSTOMY DEVICE. THERE WERE NO PT 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 BUTTON REPLACEMENT GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00568290 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other