BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS WINDOW NEEDLE GUIDE (V-WING)

    MDR report key: 3653225 · Received January 14, 2014

    Report

    Report Number
    3653225
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    December 10, 2013
    Report Date
    January 13, 2014
    Manufacturer
    VITAL ACCESS CORPORATION
    Product Code
    PFH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF DIFFICULTY WITH CANNULATION WITH VENOUS WINDOW NEEDLE GUIDE ALSO KNOWN AS V-WING DEVICE. SHE HAS NOT BEEN USING V-WING FOR CANNULATION OF THE FISTULA FOR PURPOSE OF HEMODIALYSIS SINCE (B)(4) 2013. ADDITIONALLY, THERE WAS A COMPLAINT OF PAIN ON CANNULATION THROUGH THE DEVICE AND DIFFICULTY TO OBTAIN ADEQUATE BLOOD RETURN THROUGH V-WING SITE. DISTAL V-WING SITE PROBLEMS WERE WORSE THAN THE PROXIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34507 VENOUS WINDOW NEEDLE GUIDE (V-WING) V-WING PFH VITAL ACCESS CORPORATION 7 MM, DEPTH 8MM 11-0093

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other SURGICAL REMOVAL OF TWO IMPLANTED V-WING DEVICES