BEUDAMED
    FDA Adverse Event Other Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1048136 · Received May 13, 2008

    Report

    Report Number
    1048136
    Event Type
    Other
    Date Received
    May 13, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETE LEFT AND RIGHT HEART CATHETERIZATION, A MYNX VASCULAR CLOSURE DEVICE WAS USED TO SEAL GROIN SITE. UPON REMOVAL OF MYNX DEVICE, BALLOON WAS MISSING FROM TIP. CARDIOLOGIST SPOKE TO MYNX SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB ACCESS CLOSURE, INC. MX 6700 F0803004

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR DEVICE FORWARDED TO ACI FOR QUALITY REVIEW