BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET

    MDR report key: 1899947 · Received November 10, 2010

    Report

    Report Number
    1820334-2010-00552
    Event Type
    Death
    Date Received
    November 10, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 13, 2010
    Manufacturer
    COOK INC
    Product Code
    EZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT CODE: PERITONITIS AND DEATH/EXPIRED IS NOT ADDRESSED IN THE IFU. USE OF THIS DEVICE IS PROVIDED IN THE IFU. NO PRODUCT WAS RETURNED. AN IFU IS PROVIDED, IN WHICH IT IS STATED: "DO NOT WITHDRAW THE LOOP SO FAR THAT IT BEGINS TO ENTER THE GASTROSTOMY TRACT; DOING SO MAY RESULT IN WITHDRAWAL OF CATHETER SIDEHOLES INTO THE TRACT, AND IS NOT NECESSARY FOR APPOSITION OF THE STOMACH TO THE ABDOMINAL WALL. USE FLUOROSCOPY TO FACILITATE PROPER POSITIONING OF THE CATHETER LOOP." IN THE INFO PROVIDED, THE CUSTOMER STATES, "IN THIS OTHER HOSPITAL THEY MANIPULATED THE CATHETER, SO THEY PULLED THE CATHETER OUT OF THE BODY UNTIL THE FIRST SIDE HOLE WAS SEEN, THEN THEY PUSHED IT BACK INTO THE PT." THE SIDEPORT THAT THE CUSTOMER DESCRIBES SEEING IS LOCATED WITHIN THE LOCKING LOOP. THEREFORE, IN ORDER TO VIEW THIS SIDEHOLE, THE CATHETER HAD TO HAVE BEEN IN A UNLOCKED POSITION. IT IS POSSIBLE THAT AFTER PULLING A PORTION OF THIS CATHETER OUT, THE CATHETER UNLOCKED AND WAS NOT PROPERLY REPLACED BACK INTO THE PT'S STOMACH. THIS IS LIKELY WHAT LED TO THE PT DEVELOPING PERITONITIS. WE WILL CONTINUE TO MONITOR FOR SIMILAR DEVICES AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL.

    Description of Event or Problem · 1

    THE WOGS-1200 WAS IMPLANTED ON FRIDAY THE 08TH OF OCTOBER AND THE MEDICAL FACILITY SEND THE PT BACK TO THE OTHER HOSPITAL. THERE THE PT GOT "ILL" ON SATURDAY THE 09TH OF OCTOBER. ON SUNDAY THE 10TH, THEY MADE A EMERGENCY OPERATION BECAUSE OF PERITONITIS. ON TUESDAY THE 12TH, THE PT EXPIRED. THE CUSTOMER TOLD THE REP WHAT HAS HAPPENED WITH THE FOLLOWING INFO: DURING THE PROCEDURE, EVERYTHING WAS FINE. THEY SENT THE PT BACK TO THE OTHER HOSPITAL. IN THIS OTHER HOSPITAL THEY MANIPULATED THE CATHETER, PULLING THE CATHETER OUT OF THE BODY OF THE PT UNTIL THE FIRST SIDEHOLE WAS SEEN. THEY THEN PUSHED IT BACK INTO THE PT. THEY DID NOT KNOW THIS "NEW" PRODUCT, SO THE CUSTOMER THINKS THIS WAS A HANDLING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET EZK CATHETER, RETENTION TYPE EZK COOK INC NA F2505100

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death