BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP BUTTON KIT

    MDR report key: 831971 · Received March 26, 2007

    Report

    Report Number
    6000048-2007-00102
    Event Type
    Death
    Date Received
    March 26, 2007
    Date of Event
    February 19, 2007
    Report Date
    February 26, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    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

    THE DEVICE EVALUATION CONFIRMED THAT THE BLUE TIP HAD DETACHED FROM THE SILICONE TUBE; THE CAUSE OF THE DETACHMENT IS UNKNOWN. PRIOR TO PRODUCT DISTRIBUTION, THE CATHETER AND IT'S TIP MET THE REQUIRED DIMENSIONAL SPECIFICATIONS. ADDITIONALLY, A SAMPLING OF THE LOT PASSED THE REQUIRED PHYSICAL TESTS DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THE PERTINENT LOT; NO ANOMLAIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THIS LOT. THE FEBRUARY 2007 15-MONTH PRODUCT FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 02/26/2007, THAT WITHIN ONE WEEK OF AN INITIAL PLACEMENT OF A ONE STEP BUTTON KIT ENTERAL FEEDING DEVICE, THE PT DIED (MALE, AGE UNKNOWN). THE INITIAL PLACEMENT OF THE ONE STEP BUTTON KIT WAS PERFORMED ONE WEEK EARLIER. THE BUTTON AND THE DELIVERY DEVICE PASSED THROUGH THE STOMA, PREVENTING PROPER DEVICE PLACEMENT. SUBSEQUENTLY, THE "BLUE TIP OF THE DEVICE DETACHED OUTSIDE THE BODY DURING REMOVAL". THE STOMA SITE WAS COVERED WITH GAUZE AND "THE PHYSICIAN DIDN'T THINK OF REPLACING THE DEVICE TO A NEW ONE AT THAT TIME". "THE PT CONDITION WAS OKAY PRIOR TO AND AFTER THE PROCEDURE". A SECOND ATTEMPT TO PLACE THE FEEDING DEVICE WAS PLANNED SIX DAYS LATER; HOWEVER, THE PT HAD ALREADY EXPIRED. THE DATE AND CAUSE OF DEATH IS "UNKNOWN, BUT THE PHYSICIAN DOES BELIEVE THAT IT [HAS] NOTHING TO DO WITH THE DEVICE". ATTEMPTS TO OBTAIN AUTOPSY INFORMATION WERE TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON KIT KGC KGC BOSTON SCIENTIFIC CORP. M00568520 9203317

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death