BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION US

    MDR report key: 1253096 · Received December 5, 2008

    Report

    Report Number
    2182269-2008-00349
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 10, 2008
    Report Date
    December 4, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. 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 OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCT THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIOSEAL EVOLUTION WAS DEPLOYED WITHOUT INCIDENT ON AN ACUTE MI PATIENT. FORTY-FIVE MINUTES POST DEPLOYMENT, THE PATIENT'S HEART RATE AND BLOOD PRESSURE DROPPED. THE PATIENT COMPLAINED OF TENDERNESS IN THE STOMACH UPON TOUCH. FLUIDS WERE OPENED, AND THE PATIENT WAS PUT IN A TRENDELENBURG POSITION. A CT SCAN REVEALED RETROPERITONEAL BLEEDING. THE PATIENT'S HEMOGLOBIN HAD DROPPED 2 GRAMS. A FEMSTOP WAS PLACED AND THE PATIENT IS NOW RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION US ANGIO-SEAL MGB ST. JUDE MEDICAL NA 2711248

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R THE PATIENT WAS TAKING PRESCRIBED| ANTI-COAGULANTS (DOSE UNKNOWN).