BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOVIVE¿ STANDARD PEG KIT

    MDR report key: 2851409 · Received November 29, 2012

    Report

    Report Number
    3005099803-2012-05448
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    October 27, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, IT WAS REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT HAS BEEN DISPOSED; 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 AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SUFFERING FROM MANY DISEASES AND HAD DEMENTIA. ON (B)(6) 2012, THE PATIENT PULLED THE PEG DEVICE OUT OF HIS BODY AND DEVELOPED PERITONITIS. THE PHYSICIAN PERFORMED EMERGENCY SURGERY TO REMOVE APPROXIMATELY 1.5 LITERS OF BLOOD FROM THE PATIENT'S ABDOMEN. A FOLEY CATHETER WAS PLACED DURING SURGERY. THE NEXT DAY, THE PATIENT PULLED OUT HIS FOLEY CATHETER. IT WAS REPORTED THAT THE PATIENT DIED A FEW DAYS LATER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PEG WAS PLACED BECAUSE THE PATIENT HAD SUFFERED A STROKE. THE PATIENT ALSO HAD DEMENTIA. ON (B)(6) 2012, THE PATIENT PULLED THE PEG DEVICE OUT OF HIS BODY AND DEVELOPED PERITONITIS DUE TO FOOD MOVING FROM THE STOMACH TO THE ABDOMINAL CAVITY. THE PHYSICIAN BELIEVES "IT IS TOO EASY TO DRAW THE PEG OUT OF THE STOMA." THE PHYSICIAN PERFORMED EMERGENCY SURGERY ON (B)(6) 2012 AND REMOVED APPROXIMATELY 1.5 LITERS OF BLOOD FROM THE PATIENT'S ABDOMEN. THE BLOOD IN THE ABDOMEN CAME FROM A BLOOD VESSEL IN THE STOMACH, WHICH WAS LIKELY CAUSED BY THE REMOVAL OF THE PEG DEVICE. A FOLEY CATHETER WAS PLACED DURING SURGERY. THE NEXT DAY, THE PATIENT PULLED OUT HIS FOLEY CATHETER. IT WAS REPORTED THAT THE PATIENT DIED A FEW DAYS LATER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SUFFERING FROM MANY DISEASES AND HAD DEMENTIA. ON (B)(6) 2012, THE PATIENT PULLED THE PEG DEVICE OUT OF HIS BODY AND DEVELOPED PERITONITIS. THE PHYSICIAN PERFORMED EMERGENCY SURGERY TO REMOVE APPROXIMATELY 1.5 LITERS OF BLOOD FROM THE PATIENT'S ABDOMEN. A FOLEY CATHETER WAS PLACED DURING SURGERY. THE NEXT DAY, THE PATIENT PULLED OUT HIS FOLEY CATHETER. IT WAS REPORTED THAT THE PATIENT DIED A FEW DAYS LATER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE¿ STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568391

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LOW MOLECULAR HEPARIN