BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1221222 · Received November 4, 2008

    Report

    Report Number
    2182269-2008-00247
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    August 15, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. 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 FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES 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 PROCEDURE. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), AN ANGIO-SEAL WAS SELECTED TO USE IN THE COMMON FEMORAL ARTERY (CFA). A PRE-DEPLOYMENT ANGIOGRAM REVEALED MILD CALCIFICATION AT THE PUNCTURE SITE AND THE LUMEN DIAMETER WAS OVER 4MM. A 7F ZEON SHEATH WAS ALSO USED. THREE HOURS AFTER THE PROCEDURE, THE PUNCTURE SITE BLED AND A HEMATOMA FORMED. MANUAL COMPRESSION WAS APPLIED FOR THREE HOURS WHILE BLOOD TRANSFUSION WAS GIVEN TO THE PATIENT (AMOUNT UNKNOWN), AND HEMOSTASIS WAS ACHIEVED. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 2074745

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention