BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 1823390 · Received August 25, 2010

    Report

    Report Number
    2182269-2010-00153
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVAL COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR 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 INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LEFT HEART CATHETERIZATION AND LEFT VENTRICULOGRAPHY, AN ANGIO-SEAL WAS SELECTED FOR USE IN THE RIGHT COMMON FEMORAL ARTERY (RFA). MULTIPLE ATTEMPTS WERE MADE FOR INITIAL ARTERIAL ACCESS AND ULTRASOUND WAS USED TO ASSIST THE PUNCTURE. FOLLOWING THE PROCEDURE, A CINE WAS PERFORMED OF THE PRE-DEPLOYMENT IN THE RFA AND THE ANGIO-SEAL WAS DEPLOYED. THE PT EXPERIENCED BLEEDING. THE PT WAS TRANSFERRED TO THE FLOOR. THE TECH HELD PRESSURE AND AS SOON AS PRESSURE WAS RELEASED, THE PT EXPERIENCED ARTERIAL BLEEDING AND MANUAL PRESSURE WAS APPLIED AGAIN. AN ULTRASOUND WAS PERFORMED TO DIAGNOSE THE BLEEDING. THE PT DEVELOPED A HEMATOMA AND BLOOD WAS ADMINISTERED. THE PT WAS REPORTED IN A STABLE CONDITION AND HAS BEEN DISCHARGED WITH THE RIGHT GROIN ECCHYMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL EVOLUTION MGB ST. JUDE MEDICAL NA 3128823

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R