BEUDAMED
    FDA Adverse Event Death Summary report: N

    PEG-24 BALLOON REPLACEMENT TUBE

    MDR report key: 494512 · Received November 10, 2003

    Report

    Report Number
    1037905-2003-00181
    Event Type
    Death
    Date Received
    November 10, 2003
    Date of Event
    July 14, 2003
    Report Date
    October 9, 2003
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TO CHANGE THE PATIENT'S FEEDING TUBE FROM A 24 FRENCH TUBE TO A WILSON-COOK 24 FRENCH BALLOON REPLACEMENT GASTRIC FEEDING TUBE. FIFTEEN DAYS AFTER THE NEW FEEDING TUBE WAS PLACED, THE PHYSICIAN NOTED BLEEDING FROM A GASTRIC ULCER LOCATED AT THE OPPOSITE SITE OF THE FEEDING TUBE TIP. THE PHYSICIAN IMMEDIATELY PERFORMED ENDOSCOPIC INTERVENTION TO STOP THE BLEEDING BY BERIPLASTY. HOWEVER, REBLEEDING OCCURRED. THEN, TRANSCATHETER ARTERIAL EMBOLIZATION WAS PERFORMED. WHEN AN ANGIOGRAPHY WAS PERFORMED, BLEEDING WAS OBSERVED. SELECTIVE TRANSCATHETER ARTERIAL EMBOLIZATION WITH USE OF MEDICAL-GRADE ADHESIVE (HISTOACRYL AND LIPIODOL MIXTURE) WAS PERFORMED. AT THIS TIME, THE BLEEDING WAS UNDER CONTROL. HOWEVER, THE PATIENT EXPIRED DUE TO MULTI ORGAN FAILURE FROM PREEXISTING MASSIVE BLEEDING AND TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG-24 BALLOON REPLACEMENT TUBE GASTRIC FEEDING DEVICES KNT WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R