BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2080527 · Received April 22, 2011

    Report

    Report Number
    2182269-2011-00073
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ANGIO-SEAL WAS SELECTED FOR CLOSURE VIA THE RIGHT FEMORAL ARTERIOTOMY. DURING PULLBACK, THE SHEATH BECAME STUCK AT THE SKIN SURFACE, BUT THE GREEN MARK ON THE SUTURE WAS STILL VISIBLE. THE SUTURE RELEASE BUTTON WAS PRESSED AND UPON LAYING THE DEVICE DOWN, SOME BLEEDING AT THE PUNCTURE SITE WAS OBSERVED. THE COMPACTION TUBE WAS THEN CUT AND MANUAL COMPRESSION WAS APPLIED FOR APPROXIMATELY TWO MINUTES AND THE PT WAS REPORTED TO BE OKAY. A PRECAUTIONARY ULTRASOUND WAS PERFORMED IMMEDIATELY FOLLOWING THE PROCEDURE. THE RESULTS REVEALED A HEAVILY CALCIFIED PLAQUE CAUSING NEAR TO TOTAL OCCLUSION OF THE ARTERY. THE COLLAGEN AND ANCHOR COULD BE VISIBLY SEEN DURING THE ULTRASOUND. THE PT'S FOOT WAS NOTED TO BE PINK AND WARM. NO FURTHER INTERVENTION OR EXAMINATION OF THE SUPERFICIAL FEMORAL ARTERY WAS PLANNED. THE PT WAS BEING MONITORED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3139672

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R