BEUDAMED
    FDA Adverse Event Summary report: N

    VWNG

    MDR report key: 3151696 · Received May 24, 2013

    Report

    Report Number
    MW5030438
    Date Received
    May 24, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    VITAL ACCESS
    Product Code
    PFH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS PART OF A CLINICAL TRIAL OF VENOUS WINDOW NEEDLE GUIDE IMPLANTED UNDER IDE ON (B)(6) 2011. THE NEEDLE GUIDE WAS DIFFICULT TO CANNULATE AND PT REQUESTED IT BE REMOVED (B)(6) 2013. ONLY 10 DEGREES ANGULATION. DEVICE WELL-INCORPORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233096 VWNG VENOUS WINDOW NEEDLE GUIDE PFH VITAL ACCESS 8MM 110093

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other