BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    400 MICRON FIBER PROCEDURE KIT

    MDR report key: 7007202 · Received November 7, 2017

    Report

    Report Number
    1319211-2017-00117
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 27, 2017
    Report Date
    January 18, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    UDI-DI
    H787EVLTPVAK5
    PMA / PMN Number
    K041957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN THE REPORTED DEVICE. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE REPORTED DEFECTIVE DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. AS A DEVICE EVALUATION COULD NOT BE PERFORMED, A ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED. THE CUSTOMER'S REPORTED COMPLAINT OF A FRACTURED FIBER COULD NOT BE CONFIRMED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. ANGIODYNAMICS' SUPPLIER OF THIS DEVICE WAS NOTIFIED OF THE EVENT VIA (B)(4). PER THE VENDOR'S SCAR RESPONSE, AT THE VENDOR FACILITY, MANUFACTURING AND INSPECTIONS PROCEDURES INCLUDE A 100% INSPECTION OF THE ENTIRE FIBER, INCLUDING THE QUALITY OF EACH STRIP. EACH UNIT IS ALSO REPEATEDLY BENT AND COILED DURING THE PROCESSING AND THERE IS A FINAL VISUAL INSPECTION PERFORMED WITH A HENE LASER TO CHECK THE ENTIRE FIBER LENGTH FOR DEFECTS PRIOR TO PACKAGING AND SHIPMENT. DURING THE HENE LASER TEST THE FIBER TIP IS EXAMINED CLOSELY FOR DAMAGE. DURING THE PACKAGING STEP, THE FIBERS ARE INSPECTED FOR DAMAGE. WITHOUT RECEIVING PRODUCT TO EVALUATE, THE ROOT CAUSE CANNOT BE DETERMINED, ALTHOUGH IT IS UNLIKELY THAT THE FIBER WAS FRACTURED PRIOR TO PACKAGING. THE MOST LIKELY ROOT CAUSE TO THIS EVENT IS DUE TO HANDLING AFTER THE DEVICE LEFT THE ANGIODYNAMICS FACILITY. A REVIEW OF THE ANGIODYNAMICS' DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE DIRECTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS THE FOLLOWING STATEMENT "PRIOR TO AND DURING USE, AVOID DAMAGING THE FIBER BY STRIKING, STRESSING OR EXCESSIVE BENDING. DO NOT COIL THE FIBER TIGHTER THAN A RADIUS OF 60MM". 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. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    AS REPORTED TO ANGIODYNAMICS ON OCTOBER 31, 2017: DURING PREPARATION FOR THE PROCEDURE, WHEN THE LASER FIBER WAS REMOVED FROM THE STERILE PACKAGING, IT WAS NOTED THE FIBER WAS FRACTURED. THE 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 DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786345 400 MICRON FIBER PROCEDURE KIT VENACURE ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 5233786 H787EVLTPVAK5

    Patients

    Seq Age Sex Outcome Treatment
    1