BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2190626 · Received July 22, 2011

    Report

    Report Number
    3003681312-2011-00053
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 RECEIVED, 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 THAT AN ANGIO-SEAL DEVICE WAS DEPLOYED SUCCESSFULLY. THE DAY AFTER THE PROCEDURE, THE PATIENT DEVELOPED A HARD LUMP AT THE PUNCTURE SITE, WITH PULSATILE BLOOD FLOW. TREATMENT OF THE SITE INCLUDED DIGITAL PRESSURE FOR FIFTEEN MINUTES, REST IN BED, AND A BLOOD TRANSFUSION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. THE PATIENT IS STABLE AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3233217

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R MIDAZOLAM| CEFTRIAXONE| ANGIOMAX| FENTANYL| GTN INTRACORONARY| (ALL DOSAGES UNKNOWN)