BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL EVOLUTION

    MDR report key: 1895406 · Received November 4, 2010

    Report

    Report Number
    2182269-2010-00206
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 INSTRUCTIONS FOR USE (IFU) STATE 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. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT A PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGIO-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

    IT WAS REPORTED AN ANGIO-SEAL WAS SELECTED FOR USE TO CLOSE THE RIGHT FEMORAL ARTERY. SOMETIME AFTER DEPLOYMENT, WHILE THE PATIENT WAS IN A HOSPITAL ROOM, A PULSATILE 4-5CM HEMATOMA HAD FORMED AT THE PUNCTURE SITE. MANUAL COMPRESSION WAS APPLIED FOR APPROXIMATELY 240 MINUTES, TO CONTROL THE BLEEDING. THE PATIENT WAS TAKEN IN FOR AN ULTRASOUND, WHICH REVEALED A PSEUDOANEURYSM. ULTRASOUND GUIDED COMPRESSION WAS USED TO TREAT THE PSEUDOANEURYSM AND THE PATIENT WAS REPORTED TO BE STABLE AFTER THE PROCEDURE. THE PATIENT HAS A MEDICAL HISTORY OF: DIABETES, HYPERCHOLESTEROLEMIA, AND CORONARY ARTERY DISEASE. THE PATIENT WAS PRESCRIBED THE FOLLOWING MEDICATIONS: CLOPIDOGREL, HEPARIN, AND ASPIRIN, DOSAGES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL EVOLUTION ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3139672

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R