BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVAK - 400 MICRON FIBER PROCEDURE KIT

    MDR report key: 4992475 · Received August 4, 2015

    Report

    Report Number
    1319211-2015-00319
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 7, 2015
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    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 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 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

    RETURNED FOR EVALUATION WAS AN EVLT FIBER. A VISUAL EVALUATION OF THE DISPOSABLE DEVICE NOTED THE FIBER WAS FRACTURED INTO TWO PIECES. THE CUSTOMERS REPORTED COMPLAINT OF THE FIBERS BROKEN IS THE PACKAGE IS CONFIRMED. A ROOT CAUSE FOR THE COMPLAINT DESCRIPTION CANNOT BE DEFINITIVELY DETERMINED, ALTHOUGH IT IS UNLIKELY THAT THE KIT WAS PACKAGED WITH THE BROKEN COMPONENT. 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. THE INSTRUCTIONS 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". DURING THE MANUFACTURING PROCESS, THE DEVICE GOES THROUGH SEVERAL AOL INSPECTIONS. 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. 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 ON (B)(6) 2015, A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, WHEN OPENING THE STERILE PACKAGING, 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. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510690 PVAK - 400 MICRON FIBER PROCEDURE KIT ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS, INC. 006144

    Patients

    Seq Age Sex Outcome Treatment
    1