BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1232162 · Received November 14, 2008

    Report

    Report Number
    3003681312-2008-00115
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE 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 INSTRUCT THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT AN AV FISTULA OR PSEUDOANEURYSM ARE POSSIBLE RISK OR SITUATIONS 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 FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) USING A 6F INTRODUCER SHEATH, A 6F ANGIO-SEAL VIP WAS SUCCESSFULLY USED TO CLOSE THE ARTERIOTOMY. THE LOCATION OF THE ARTERY WAS CONFIRMED BY BLOOD FLOW AND INSERTION STEPS WERE FOLLOWED PER IFU. HEMOSTASIS WAS ACHIEVED. TWELVE HOURS LATER WHEN THE PATIENT AMBULATED BLEEDING OCCURRED. A PSEUDOANEURYSM WAS IDENTIFIED. THE PSEUDOANEURYSM WAS SUCCESSFULLY MANAGED WITH ULTRASOUND GUIDED COMPRESSION THERAPY. THE PATIENT WAS TAKING A THROMBOLYTIC AGENT, TYPE AND DOSE UNKNOWN. THE PHYSICIAN IS IN THE ANGIO-SEAL TRAINING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2152739

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention