BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVAK - 400 MICRON FIBER PROCEDURE KIT

    MDR report key: 4906701 · Received July 7, 2015

    Report

    Report Number
    1319211-2015-00313
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 22, 2015
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER, AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A F/UP MEDWATCH. A REVIEW OF THE 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.

    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 CUSTOMERS REPORTED COMPLAINT OF THE FIBER BROKEN IN PACKAGING IS UNABLE TO BE CONFIRMED SINCE NO PRODUCT WAS RETURNED FOR EVALUATION. WITHOUT RECEIVING PRODUCT TO EVALUATE, WE ARE UNABLE TO DEFINITIVELY DETERMINE ROOT CAUSE FOR THIS EVENT. DURING THE MANUFACTURING PROCESS, FIBERS ARE REPEATEDLY BENT AND COILED AND THERE IS A FINAL VISUAL INSPECTION PERFORMED WITH A HENE LASER TO CHECK THE ENTIRE FIBER LENGTH FOR DEFECTS PRIOR TO PACKAGING SHIPMENT. 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.

    Description of Event or Problem · 1

    AS REPORTED, ON (B)(6) 2015, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. AT THE START OF THE PROCEDURE, THE TIP OF THE FIBER FRACTURED OFF. 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. IT WAS REPORTED THE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISPOSED OF BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439520 PVAK - 400 MICRON FIBER PROCEDURE KIT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS, INC. 006157

    Patients

    Seq Age Sex Outcome Treatment
    1