BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE NEVERTOUCH DIRECT

    MDR report key: 3843623 · Received May 27, 2014

    Report

    Report Number
    1319211-2014-00065
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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 MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS REPORTED, THE PT SUFFERED NO PERMANENT HARM OR INJURY DUE TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, (B)(6), FEMALE PT PRESENTED FOR ENDOVENOUS LASER PROCEDURE. IT WAS REPORTED THAT WHEN THE TREATING PHYSICIAN WITHDREW THE FIBER FROM INSIDE THE PT, THE TIP OF THE FIBER HAD FRACTURED OFF INSIDE OF THE PT. THE PT WAS TAKEN TO THE OP, WHERE THE FRACTURED PIECE OF THE FIBER WAS SUCCESSFULLY REMOVED. 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
    311816 VENACURE NEVERTOUCH DIRECT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 608469

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention