BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP BUTTON¿

    MDR report key: 2469202 · Received February 27, 2012

    Report

    Report Number
    3005099803-2012-00566
    Event Type
    Death
    Date Received
    February 27, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KGC
    PMA / PMN Number
    K910584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THE PRODUCT 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 A PATIENT WITH A HISTORY OF OVARIAN CANCER AND INTERSTITIAL LUNG DISEASE WAS ADMITTED TO THE HOSPITAL (B)(6) 2012 BECAUSE IT BECAME DIFFICULT FOR THE PATIENT TO INGEST ORALLY. AN ESTABLISHMENT FOR A GASTROSTOMA WAS GOING TO BE PERFORMED, HOWEVER AN X-RAY SHOWED SEVERE INTERSTITIAL LUNG DISEASE, THEREFORE THE PEG PLACEMENT WAS POSTPONED. ON (B)(6) 2012 THE PATIENT'S CONDITION IMPROVED AND A ONE STEP BUTTON INITIAL PLACEMENT GASTROSTOMY KIT WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PEG PLACEMENT WAS CHECK VIA AN X-RAY. THIS PATIENT WAS REPORTED TO BE THIN AND THE ABDOMINAL WALL WAS THIN, THIS DEVICE WAS SLIGHTLY LONG. FIVE SPACER DISKS AND GAUZE WERE PLACED. ON (B)(6) 2012 A CT SCAN WAS PERFORMED TO CHECK PLACEMENT AND THERE WAS NO ISSUE WITH THE DEVICE. THE FIVE SPACER DISKS AND GAUZE WERE REMOVED. ON (B)(6) 2012 (200ML) ENTERAL NUTRIENT WAS INJECTED THREE TIMES. (1000ML) INFUSION WAS INJECTED ONE TIME. ON (B)(6) 2012 (200ML) ENTERAL NUTRIENT WAS INJECTED THREE TIMES. (1000ML) INFUSION WAS INJECTED ONE TIME. ON (B)(6) 2012 (300ML) ENTERAL NUTRIENT WAS INJECTED THREE TIMES. (500ML) INFUSION WAS INJECTED ONE TIME. ON (B)(6) 2012 DURING THE AFTERNOON THE PATIENT COMPLAINED OF STOMACH PAIN. A CT SCAN WAS PERFORMED AND AIR WAS DETECTED IN THE ABDOMINAL CAVITY. THE PHYSICIAN EXPLORED THE PATIENT'S ABDOMEN BY PALPATION AND CONFIRMED INDURATION OF A PORTION OF THE GASTROSTOMY. THE PHYSICIAN DIAGNOSED THE PATIENT WITH PERITONITIS. THE PATIENT WAS SENT TO THE HOSPITAL WHERE EMERGENCY SURGERY WAS PERFORMED TO REMOVE THE ONE STEP BUTTON DEVICE. THE OPERATION TOOK APPROXIMATELY ONE HOUR. THE DEVICE WAS CHECKED UPON REMOVAL IT WAS NOTED THERE WERE NO ISSUES. IN THE MIDDLE OF THE NIGHT ON (B)(6) 2012 THE PATIENT HAD RESPIRATORY DIFFICULTIES AND DIED. THE PHYSICIAN STATED "THE PATIENT'S OVERALL STATUS BECAME WORSE BY THE PERITONITIS AND RESULTED IN DEATH FROM RESPIRATORY FAILURE RAISED BY INGRAVESCENCE OF INTERSTITIAL LUNG DISEASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP BUTTON¿ TUBE, GASTRO-ENTEROSTOMY KGC BOSTON SCIENTIFIC - SPENCER M00568520 14521078

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death