BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 4232303 · Received October 21, 2014

    Report

    Report Number
    1319211-2014-00144
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVAL WILL BE SENT VIA A F/U MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. COMPLAINT #: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A PT OF UNK AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING WITHDRAWAL OF THE GUIDEWIRE, IT WAS NOTED THE GUIDEWIRE HAD PARTIALLY UNRAVELED. THE GUIDEWIRE DID NOT FRACTURE AND THE PT WAS NOT HARMED. THE GUIDEWIRE WAS SET ASIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THE PT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668019 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 4770541

    Patients

    Seq Age Sex Outcome Treatment
    1