BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    MDR report key: 2864238 · Received December 10, 2012

    Report

    Report Number
    9616099-2012-00736
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MGB
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW, THE PREVIOUSLY REPORTED EVENT WAS REPORTED IN ERROR AS THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT THE NECESSITY OF ANY ADDITIONAL INTERVENTIONS. THEREFORE, IT DOES NOT MEET THE CRITERIA OF A SERIOUS INJURY OR A MALFUNCTION PER THE REGULATORY GUIDELINES. NO FURTHER INFORMATION IS AVAILABLE AND ADDITIONAL REPORTS WILL NOT BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PHYSICIAN PULLED OUT SHEATH AND EXOSEAL VASCULAR CLOSURE DEVICE 6 FRENCH (OUS) TOGETHER SLOWLY . PULSATILE FLOW STOPPED AND HE PULLED OUT THE EXOSEAL ABOUT 2 CM BUT THE INDICATOR WINDOW TURNED TO SOLID BLACK WHEN THE EXOSEAL DISTAL TIP ALMOST CAME OUT FROM THE PATIENT. THE PHYSICIAN THOUGHT IT WAS NOT THE RIGHT TIMING TO DEPLOY THE PLUG. THEREFORE, HE REMOVED THE EXOSEAL AND FINISHED THE PROCEDURE WITH MANUAL COMPRESSION WITHOUT DEPLOYING THE PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXOSEAL VASCULAR CLOSURE DEVICE (VCD) VASCULAR CLOSURE DEVICE MGB CORDIS DE MEXICO NA 15517369

    Patients

    Seq Age Sex Outcome Treatment
    1