BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 1631942 · Received March 12, 2010

    Report

    Report Number
    2182269-2010-00046
    Event Type
    Death
    Date Received
    March 12, 2010
    Report Date
    March 12, 2010
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT AN AV FISTULA OR PSEUDOANEURYSM IS POSSIBLE RISKS OR SITUATIONS ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS SELECTED FOR USE. THE PATIENT EXPERIENCED PSEUDOANEURYSM AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC) WHICH CAUSED DEATH OF THE PATIENT. THE EVENT AND DEATH DATES ARE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL EVOLUTION MGB ST. JUDE MEDICAL, INC. NA 2806409

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R