BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOVIVE? LOW PROFILE REPLACEMENT BUTTON

    MDR report key: 3223435 · Received July 12, 2013

    Report

    Report Number
    3005099803-2013-06369
    Event Type
    Death
    Date Received
    July 12, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED IN A PEG REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2013, THE PATIENT VOMITED AFTER NUTRITION ADMINISTRATION. IT WAS REPORTED THAT THE NUTRITION LEAKED INTO THE PATIENT¿S PERITONEAL CAVITY. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED IT REVEALED THE BOLSTER WAS WITHIN THE STOMACH AND WAS COVERED BY GASTRIC MUCOSA. IT WAS ALSO DISCOVERED THAT THE PATIENT HAD FREE AIR IN ABDOMINAL CAVITY. THE BUTTON WAS REMOVED AND REINSERTED ON THE SAME DAY. A SCOPE WAS USED TO CONFIRM THAT THE BOLSTER WAS PROPERLY IMPLANTED. THE PATIENT WAS TRANSFERRED INTO (B)(6) AND WAS PRESCRIBED A MEDICATION. IN THE EVENING OF (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT¿S CONDITION HAD IMPROVED HOWEVER THE SAME EVENING, THE PATIENT¿S CONDITION DETERIORATED. THE PHYSICIAN ADVISED THAT THE PATIENT UNDERGO INTRA PERITONEAL IRRIGATION BUT THE PATIENT¿S FAMILY REFUSED THE PROCEDURE. THE PATIENT DIED AT 5:00 AM OF (B)(6) 2013 DUE TO PERITONITIS. NO AUTOPSY WAS PERFORMED AS PER THE FAMILY¿S REQUEST.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BUTTON REPLACEMENT GASTROSTOMY DEVICE WAS USED IN A PEG REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2013, THE PATIENT VOMITED AFTER NUTRITION ADMINISTRATION. IT WAS REPORTED THAT THE NUTRITION LEAKED INTO THE PATIENT¿S PERITONEAL CAVITY. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED IT REVEALED THE BOLSTER WAS WITHIN THE STOMACH AND WAS COVERED BY GASTRIC MUCOSA. IT WAS ALSO DISCOVERED THAT THE PATIENT HAD FREE AIR IN ABDOMINAL CAVITY. THE BUTTON WAS REMOVED AND REINSERTED ON THE SAME DAY. A SCOPE WAS USED TO CONFIRM THAT THE BOLSTER WAS PROPERLY IMPLANTED. THE PATIENT WAS TRANSFERRED INTO HCU AND WAS PRESCRIBED A MEDICATION. IN THE EVENING OF (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT¿S CONDITION HAD IMPROVED; HOWEVER, THE SAME EVENING, THE PATIENT¿S CONDITION DETERIORATED. THE PHYSICIAN ADVISED THAT THE PATIENT UNDERGO INTRA PERITONEAL IRRIGATION BUT THE PATIENT¿S FAMILY REFUSED THE PROCEDURE. THE PATIENT DIED AT 5:00 AM OF (B)(6) 2013, DUE TO PERITONITIS. NO AUTOPSY WAS PERFORMED AS PER THE FAMILY¿S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324383 ENDOVIVE? LOW PROFILE REPLACEMENT BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568350

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death