BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH DIRECT

    MDR report key: 4032058 · Received August 5, 2014

    Report

    Report Number
    1319211-2014-00109
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS METS ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS REPORTED, THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(4) 2014, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, WHEN THE STERILE DEVICE PACKAGING WAS OPENED, IT WAS NOTED THE TIP OF THE FIBER WAS FRACTURED OFF INSIDE OF THE PACKAGE. THE DISPOSABLE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THE EVENT AS THE DISPOSABLE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455955 VENACURE NEVERTOUCH DIRECT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS C04082

    Patients

    Seq Age Sex Outcome Treatment
    1