BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE NEVERTOUCH DIRECT

    MDR report key: 3925329 · Received July 2, 2014

    Report

    Report Number
    1319211-2014-00096
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE REPORTED COMPLAINT SAMPLE WAS DISPOSED OF BY THE USER AND NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION . THE REPORTED COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME, ALTHOUGH, A POSSIBLE CONTRIBUTING FACTOR COULD BE DUE TO HANDLING AFTER THE FIBER WAS REMOVED FROM THE PACKAGING. IT IS POSSIBLE CONTRIBUTING FACTOR COULD BE DUE TO HANDLING AFTER THE FIBER WAS REMOVED FROM THE PACKAGING. IT IS POSSIBLE THAT THE FIBER MAY HAVE STRUCK A HARD SURFACE WHILE IN THE PROCEDURE ROOM. IF THIS DID OCCUR AND GO UNNOTICED, THE FIBER WOULD HAVE BEEN USED FOR TREATMENT AND WHILE TRAVELING THROUGH TORTUOUS VEIN AND COULD HAVE BROKEN AT THE SITE WHERE IT WAS STRUCK. ALTHOUGH THIS THEORY CANNOT BE DEFINITELY DETERMINED IT UNLIKELY TO BE DESIGN OR MANUFACTURING RELATED. 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 MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. DURING THE MANUFACTURING PROCESS, THE DISPOSABLE FIBER DEVICE RECEIVES TWO 100% INSPECTIONS AND TWO AQL INSPECTIONS IN WHICH THE QUALITY OF THE FIBER STRIP IS INSPECTED. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A (B)(6) FEMALE PATIENT PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER HAD FRACTURED OFF INSIDE OF THE PATIENT. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED VIA A CUT DOWN. IT WAS REPORTED THE PATIENT WAS NOT PERMANENTLY HARMED OR INJURED DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS THE IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385434 VENACURE NEVERTOUCH DIRECT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 607903

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention