BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 5025535 · Received August 20, 2015

    Report

    Report Number
    1319211-2015-00327
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 11, 2015
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS RELATED TOT HE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE.

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS A NEVERTOUCH FIBER. A VISUAL REVIEW OF THE FIBER NOTED NO DEFECTS WITH THE NAKED EYE. WHEN VIEWED UNDER A MICROSCOPE, THE SMA CLEAVED END APPEARED TO BE CHIPPED. SCRATCHES ARE EVIDENT ON THE CONNECTOR. FUNCTIONAL AND DIMENSIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE DEVICE PASSED ALL TESTING AND FUNCTIONED AS INTENDED. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF A FIBER BREAK IS NOT CONFIRMED AS NO FRACTURE OR CRACK WAS DISCOVERED. ALTHOUGH THE COMPLAINT FOR THE FRACTURE CANNOT BE CONFIRMED, DAMAGE WAS FOUND ON THE SMA CLEAVED END, WHICH DOES AFFECT THE PERFORMANCE OF THE FIBER. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED COMPLAINT DESCRIPTION. A POSSIBLE CONTRIBUTING FACTOR COULD BE DUE TO HANDLING DAMAGE. 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. DURING THE MANUFACTURING PROCESS, EACH FIBER RECEIVES TWO 100 PERCENT INSPECTIONS AND ONE AQL INSPECTION IN WHICH THE POWER OUTPUT VERIFIED USING A DIODE LASER AND POWER METER, AND THE PRESENCE AND CONDITION OF THE CLEAVED END ARE VERIFIED UNDER VIDEOSCOPE PRIOR TO PACKAGING. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER ADVISES THE SUER: "PRIOR TO AND DURING USE, AVOID DAMAGING THE FIBER BY STRIKING, STRESSING, OR EXCESSIVE BENDING. DO NOT COIL THE FIBER TIGHTER THAN A DIAMETER OF 20CM" AND "PULL THE SHEATH BACK AND LOCK IT TO THE SHEATH-LOK FITTING." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2015, A (B)(6) FEMALE PATIENT PRESENTED FOR AN ENDOVENOUS LASTER PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, AFTER CONNECTING THE FIBER TO VENACURE LASER UNIT, IT WAS NOTED THAT THE LASER FIBER ILLUMINATED BRIGHT RED APPROXIMATELY 10 INCHES FROM CONNECTION POINT, INDICATING THE FIBER WAS FRACTURED. THE DEVICE WAS SET ASIDE, AND A NEW OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552600 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS, INC. 4822157

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR