BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH PROCEDURE KITS

    MDR report key: 6188810 · Received December 20, 2016

    Report

    Report Number
    6188810
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 4, 2016
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE ENDOVENOUS LASER ABLATION OF RIGHT GREATER, ANTERIOR AND SMALL SAPHENOUS VEIN. CATHETER ATTACHMENT TO LASER LOCKED INTO PLACE. THE SHEATH WAS ADVANCED TO 3 CM DISTAL TO THE SFJ AND THE LASER FIBER INSERTED.  IT WAS VISUALIZED AT 2.5 CM DISTAL TO THE SAPHENOFEMORAL JUNCTION.  AT THE INITIATION OF THE LASER SHE COMPLAINED OF HIP PAIN.  THE LASER FIBER WAS REIMAGED AND FOUND TO BE BEYOND THE SFJ.  THE LASER WAS SUBSEQUENTLY REMOVED. POST PROCEDURE DUE TO CONCERNS THAT THE LASER WAS ENGAGED BEYOND THE SFJ, THE PATIENT WAS ADMINISTERED A THERAPEUTIC DOSE OF LOVENOX. ADMITTED TO HOSPITAL FOR MONITORING FOR DEEP VEIN THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839906 VENACURE NEVERTOUCH PROCEDURE KITS POWERED LASER SURGICAL INSTRUMENT GEX ANGIODYNAMICS, INC. 5083809

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NO OTHER THERAPIES