BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE

    MDR report key: 1719475 · Received June 1, 2010

    Report

    Report Number
    MW5016268
    Event Type
    Injury
    Date Received
    June 1, 2010
    Date of Event
    April 29, 2010
    Report Date
    May 28, 2010
    Manufacturer
    ACCESS CLOSURE INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED LOWER LEFT LEG PAIN POST CARDIAC CATHETERIZATION DISCHARGE. ACUTE OCCLUSION OF LOWER LEFT EXTREMITY ARTERY POST CARDIAC CATHETERIZATION AND FAILED CLOSURE DEVICE DEPLOYMENT OF UNKNOWN ORIGIN. THE EVENT OCCURRED POST DISCHARGE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT ULTRASOUND AS WELL AS MECHANICAL AND CHEMICAL THROMBECTOMY AND EVENTUAL COMPARTMENT SYNDROME INTERVENTION. OCCURRENCE REPORT DATED (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE NONE MGB ACCESS CLOSURE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization