BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 3190595 · Received June 14, 2013

    Report

    Report Number
    1319211-2013-00077
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PT DUE TO THIS EVENT. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION IN REGARDS TO THE EVENT AND PT INFORMATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFORMATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED (B)(4) 2013, A PT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE IN THE PT'S LEG. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED COMPLICATIONS. POST PROCEDURE, IT WAS NOTED THE GOLD TIP HAD DETACHED FROM THE FIBER. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PT DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272319 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX 592058

    Patients

    Seq Age Sex Outcome Treatment
    1