BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 807836 · Received January 10, 2007

    Report

    Report Number
    1317056-2007-00002
    Event Type
    Death
    Date Received
    January 10, 2007
    Date of Event
    December 4, 2006
    Report Date
    December 12, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW PERFORMED ON THE REPORTED LOT NUMBER HAD INDICATED THAT THERE WERE NO MANUFACTURING OR QUALITY DISCREPANCIES ASSOCIATED WITH THE REPORTED KIT LOT. NO PREVIOUS COMPLAINTS HAVE BEEN REC'D ON THE REPORTED LOT NUMBER. AS THE USED PRODUCT WAS DISCARDED BY THE HOSP NO FAILURE ANALYSIS WILL BE POSSIBLE. THE DFU PACKAGED WITHIN THIS KIT CLEARLY STATES "ENSURE THAT YOU ARE MAKING SECURE CONNECTIONS WHEN USING THIS DEVICE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM. ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR." BOSTON SCIENTIFIC MANUFACTURED DEVICES ARE REGULARLY SUBJECTED TO QUALITY VISUAL INSPECTIONS AND LEAK TESTS. THE EVENT DESCRIPTION AS REPORTED BY THE END USER DOES NOT ALLEGE A PRODUCT FAILURE BUT DESCRIBES AN ADVERSE EVENT IN WHICH A BOSTON SCIENTIFIC PRODUCT WAS BEING UTILIZED. WITHOUT A SAMPLE TO EXAMINE, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEN THE EVENT AND THE REPORTED DEVICE. THE INFO CONTAINED THEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING. THIS SUBMISSION IS NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION ON BEHALF OF BOSTON SCIENTIFIC THAT THE PRODUCT WHICH IS THE SUBJECT OF THIS REPORT IN ANY WAY HAS MALFUNCTIONED, WAS DEFECTIVE, OR CAUSALLY RELATED TO ANY DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    AS REPORTED BY END USER HOSPITAL IN USER FACILITY MEDWATCH (COPY ATTACHED), DURING A CARDIAC CATHETERIZATION PROCEDURE UTILIZING A BOSTON SCIENTIFIC CONVENIENCE KIT, "AIR WAS INJECTED INTO A CORONARY ARTERY. PATIENT SUSTAINED A CARDIAC ARREST, WAS RESUSCITATED, BUT DIED WITHIN 24 HOURS." THE DEVICES USED WERE DISCARDED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CONVENIENCE KIT DTL BOSTON SCIENTIFIC NA 1154197

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death