BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDWIL DOUBLE-ENDED PHLEBECTOMY AND SPATULA

    MDR report key: 1241944 · Received November 17, 2008

    Report

    Report Number
    1241944
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    September 24, 2008
    Report Date
    November 17, 2008
    Manufacturer
    TOTAL VEIN SYSTEMS
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE ON THE RIGHT LATERAL KNEE, WHEN THE SURGEON WENT TO PULL A VEIN THE HOOK BROKE AND WAS LOST IN THE PATIENT'S RIGHT LATERAL SUPERIOR CALF. A LARGER INCISION APPROXIMATELY 1 CM WAS MADE TO EXPLORE THE WOUND. FLUOROSCOPY WAS CALLED AND BROUGHT IN. THE PATIENT WAS UNDER FLUOROSCOPY. THE SURGEON WAS ABLE TO LOCATE THE TIP AND REMOVE IT. UPON PLACING IT BESIDE ANOTHER TIP THAT WAS WHOLE, IT WAS ALL INTACT. WE EVALUATED THE PATIENT'S LEG UNDER FLUOROSCOPY ABOVE AND BELOW THE AREA, AND THERE WERE NO OTHER FOREIGN BODIES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDWIL DOUBLE-ENDED PHLEBECTOMY AND SPATULA INSTRUMENT, PHELBECTOMY VEIN HOOK GDG TOTAL VEIN SYSTEMS PH1160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR