BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH DIRECT

    MDR report key: 4960981 · Received July 30, 2015

    Report

    Report Number
    1319211-2015-00321
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    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 CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF A FIBER FRACTURE IN THE SLEEVE COULD NOT BE CONFIRMED BECAUSE NO SAMPLE WAS RETURNED FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED COMPLAINT DESCRIPTION CANNOT BE DETERMINED, ALTHOUGH IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. 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. DURING THE MANUFACTURING PROCESS, THE DISPOSABLE FIBER DEVICE RECEIVES A 100% INSPECTION AND AN AQL INSPECTION IN WHICH THE QUALITY OF THE FIBER STRIP IS INSPECTED. PRIOR TO PACKAGING, ALL COMPONENTS ARE INSPECTED FOR DAMAGE.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2015, A FEMALE PATIENT OF UNKNOWN AGE PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, WHEN THE STERILE DEVICE PACKAGING WAS OPENED, IT WAS NOTED THE FIBER HAD FRACTURED 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. THE REPORTED DEFECT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498581 VENACURE NEVERTOUCH DIRECT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS, INC. 4848199

    Patients

    Seq Age Sex Outcome Treatment
    1