BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2130206 · Received June 10, 2011

    Report

    Report Number
    2182269-2011-00105
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MED, 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 INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    IT WAS REPORTED UPON PULL BACK OF THE ANGIO-SEAL, THE DEVICE SEEMED TO JUMP AND PULLED OUT. THERE WAS NO ANCHOR AND THE SUTURE WAS FRAYED. BLEEDING AT THE PUNCTURE SITE WAS OBSERVED AND MANUAL PRESSURE WAS APPLIED. THE PT'S BLOOD PRESSURE DROPPED AND IV FLUIDS WERE ADMINISTERED. THE PT RESPONDED TO THE IV FLUIDS AND THE PEDAL PULSES WERE ASSESSED AND WERE NORMAL. THE PT WAS DISCHARGED FROM THE HOSP WITH NO FURTHER ISSUES NOTED. ADD'L INFO WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3306821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R