BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1970503 · Received January 19, 2011

    Report

    Report Number
    2182269-2011-00008
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT FEMORAL ARTERY. THE FOLLOWING MORNING, WHEN THE PT GOT UP TO AMBULATE, THERE WAS A POPPING SENSATION IN THE RIGHT GROIN AND A LARGE HEMATOMA HAD FORMED. THE PT WAS INSTRUCTED TO LAY DOWN AND MANUAL COMPRESSION HAD TO BE APPLIED. HEMOSTASIS WAS ACHIEVED AND THE PT WAS REPORTED TO BE RECOVERING. THE PT'S STAY IN THE HOSPITAL HAS BEEN EXTENDED FOR FURTHER MONITORING. THE PT'S LAB VALUES WERE REPORTED STABLE AND THERE WAS NO EVIDENCE OF BLEEDING. SURGICAL INTERVENTION WAS NOT REQUIRED. ADD'L INFO WAS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R