BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VWING VASCULAR NEEDLE GUIDE, 10MM X 7MM

    MDR report key: 3853488 · Received May 28, 2014

    Report

    Report Number
    3009273792-2014-00003
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    VITAL ACCESS CORPORATION
    Product Code
    PFH
    PMA / PMN Number
    K130873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) WAS IMPLANTED WITH TWO VWING DEVICES ON A BRACHIOBASILIC FISTULA ON HER LEFT UPPER ARM ON (B)(6) 2014. BOTH VWING DEVICES WERE PALPABLE FOLLOWING IMPLANTATION. SHE WAS SEEN IN FOLLOW UP ON (B)(6) AND TOLD TO RETURN IN TWO WEEKS FOR FURTHER FOLLOW-UP. SHE NEVER SHOWED FOR THIS VISIT. THE CANNULATION CENTER BEGAN USING THE VWING TWO WEEKS AFTER THE INITIAL FOLLOW-UP (AROUND (B)(6)), BELIEVING THAT THEY HAD THE GO AHEAD. THEY HAD DIFFICULTY CANNULATING AND ATTEMPTED TO CANNULATE MULTIPLE TIMES. THE PATIENT WAS SEEN BY DR (B)(6) ON (B)(6) WITH TENDERNESS AND REDNESS CONSISTENT WITH INFECTION. DR (B)(6) REMOVED THE DISTAL (ARTERIAL) VWING. OPERATIVE FINDINGS SUGGESTED A HEMATOMA THAT GOT INFECTED WITH MULTIPLE MANIPULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312847 VWING VASCULAR NEEDLE GUIDE, 10MM X 7MM VWING PFH VITAL ACCESS CORPORATION 00145 13-0128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R AV FISTULA NEEDLES: 3X/WEEK (B)(6) 2014