BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1212468 · Received October 21, 2008

    Report

    Report Number
    2182269-2008-00236
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    p930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO REC'D, THE CAUSE FOR THE REPORTED EVENTS 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 VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE STATES THAT ONCE HEMOSTASIS IS ACHIEVED, DO NOT TAMP OR INTENTIONALLY GO BEYOND THE DISTAL END OF THE BLACK COMPACTION MARKER IN ORDER TO PREVENT ANCHOR DEFORMATION AND/OR COLLAGEN TEARING WHICH COULD RESULT IN BLEEDING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A VOLUNTARY MEDWATCH REPORT THAT FOLLOWING A PERCUTANEOUS PROCEDURE, THE VASCULAR SURGEON DEPLOYED 8F ANGIO-SEAL VIP DEVICES TO BILATERAL FEMORAL ARTERIOTOMIES. THE PT'S ACTIVATED CLOTTING TIME (ACT) WAS 180 AT THE TIME OF THE DEPLOYMENTS. AFTER 4 HRS OF BED REST, THE PT SAT UP TO AMBULATE. BLEEDING OCCURRED FROM THE LEFT ARTERIOTOMY SITE. MANUAL COMPRESSION WAS APPLIED, AND HEMOSTASIS WAS ACHIEVED. THE PT WAS ADMITTED FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA 2071384

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization