BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1080484 · Received July 21, 2008

    Report

    Report Number
    2182269-2008-00177
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 4, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT AVAILABLE. 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 IFU CAUTIONS THAT AN AV FISTULA OR PSEUDOANEURYSM ARE POSSIBLE RISKS 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 DIAGNOSTIC CARDIAC ANGIOGRAM IN PREPARATION FOR VALVE SURGERY, A 6F ANGIO-SEAL STS PLUS WAS DEPLOYED. SEVEN HOURS AFTER THE ANGIOGRAM, THE PATIENT SAT UP IN BED, FELT PAIN AND BLEEDING OCCURRED AT THE PUNCTURE SITE. THE PATIENT BECAME HYPOTENSIVE. MANUAL COMPRESSION WAS APPLIED FOLLOWED BY A FEMOSTOP. A LARGE HEMATOMA HAD DEVELOPED AND THE PATIENT RECEIVED A BLOOD TRANSFUSION. AN ULTRASOUND REVEALED A PSEUDOANEURYSM. THE PATIENT UNDERWENT A THROMBIN INJECTION, DOSE UNKNOWN. THE PATIENT WAS DISCHARGED 3 DAYS AFTER THE ANGIOGRAPHIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention