BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 1052964 · Received May 27, 2008

    Report

    Report Number
    3005099803-2008-00551
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K971906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL; THEREFORE, AN ANALYSIS IS NOT AVAILABLE. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADD'L COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. THE APRIL 2008 15-MONTH REPLACEMENT BUTTON ENTERAL FEEDING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED.

    Description of Event or Problem · 1

    ON APRIL 30, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE, WHICH WAS PLACED ON SIX DAYS EARLIER, "... LEAKED NUTRITION SEVERAL DAYS AFTER PLACEMENT". IT WAS ALSO REPORTED THAT THE DEVICE CONTINUED TO LEAK AFTER DECOMPRESSION WAS PERFORMED. AND, ACCORDING TO THE COMPLAINANT, WHEN CONNECTED TO A SYRINGE, NUTRITION WAS DRAWN, LEADING THE CUSTOMER TO SUSPECT THAT THE DEVICE BACKFLOW VALVE WAS NOT FUNCTIONING PROPERLY. AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTON REPLACEMENT GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00568180 9809444

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK