BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE EVOLUTION

    MDR report key: 2587289 · Received May 21, 2012

    Report

    Report Number
    2182269-2012-00047
    Event Type
    Injury
    Date Received
    May 21, 2012
    Report Date
    April 26, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT RETURNED, OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH CONFIRMED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGI-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT A PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGI-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

    AFTER DEPLOYMENT OF AN ANGIO-SEAL EVOLUTION DEVICE, THE PT DEVELOPED A PSEUDOANEURYSM WHICH REQUIRED SURGICAL REPAIR. THE PT'S HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. THE PT WAS LISTED AS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R