BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM

    MDR report key: 3863000 · Received June 5, 2014

    Report

    Report Number
    3009273792-2014-00001
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 23, 2014
    Manufacturer
    VITAL ACCESS CORPORATION
    Product Code
    PFH
    PMA / PMN Number
    K130873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAD TWO VWING DEVICES IMPLANTED ON A LEFT UPPER ARM BRACHIOCEPHALIC FISTULA ON (B)(6) 2014. HER VWING SITES WERE INITIALLY USED TO ACCESS HER BRACHIOCEPHALIC FISTULA ON (B)(6) 2014. CANNULATIONS CONTINUED WITH A FREQUENCY OF THREE TIMES PER WEEK UNTIL THE EVENT. ON PHYSICAL EXAMINATION, THE SITES HAD A 'FAIR AMOUNT OF REDNESS AND ALSO WARMTH'. AFTER ANGIOGRAPHY, PUS WAS 'EASILY ABLE TO BE REMOVED FROM A NEEDLE CANNULATION SITE. THEREFORE, THE VWINGS WERE REMOVED'. DURING REMOVAL OF THE DEVICES, THE DISTAL VWING WAS OBSERVED TO HAVE 'PUS WITHIN THE FLUTED AREA. THERE WAS A HEMATOMA THERE AND ALSO ONCE THE VWING WAS MOBILIZED THERE WAS A VERY LARGE DEFECT' IN THE VESSEL WALL. DUE TO THE LOSS OF VASCULAR INTEGRITY, THE FISTULA WAS LIGATED NEAR THE ELBOW. THE SITES WERE COPIOUSLY IRRIGATED AND DRIED. THE VWINGS WERE REMOVED COMPLETELY AND THE WOUND WAS PACKED WITH IODOFORM GAUZE'. THE WOUND SITES WERE CULTURED AND WERE DETERMINED AND TO BE A LOCALIZED (B)(6) INFECTION. NO BLOODSTREAM INFECTION OR SEPSIS HAD OCCURRED. NS WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2014. SHE IS CURRENTLY DIALYZING USING A CENTRAL VENOUS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329485 VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM VWING PFH VITAL ACCESS CORPORATION 00144 13/0127

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R AV FISTULA NEEDLES: 3X/WEEK (B)(6) 2014