BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE1470

    MDR report key: 3982608 · Received June 24, 2014

    Report

    Report Number
    1319211-2014-00088
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K110225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR ASSESSMENT AND REPAIR WAS ONE VENACURE 1470 UNIT (SN (B)(4)), ASSESSMENT OF THE UNIT DETERMINED THE UNIT FUNCTIONED AS INTENDED. THE CUSTOMER'S COMPLAINT DESCRIPTION OF PULSING OF THE FIBER DURING THE PROCEDURE CANNOT BE CONFIRMED AS THE LASER WAS THOROUGHLY TESTED AND MET ALL SPECIFICATIONS. ALTHOUGH THE EXACT ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED, IT DOES NOT APPEAR TO BE THE RESULT OF A MANUFACTURING OR DESIGN FAILURE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). THE REVIEW CONFIRMS THAT THE UNIT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE USER MANUAL (VENACURE 1470 OPERATOR MANUAL US, VERSION 2.0), WHICH IS SUPPLIED TO THE USER WITH THIS UNIT LISTS PAIN AS A POTENTIAL ADVERSE EFFECT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE DISPOSABLE FIBERS THE CUSTOMER HAD RECEIVED IN THE PREVIOUS 6 MONTHS OBTAINED THROUGH THE SHR FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMED THAT THE PACKAGING LOT AND ALL COMPONENT LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. IT WAS REPORTED THE PATIENT IS STABLE AND SUFFERED NO HARM OR INJURY DUE TO THE EVENT. 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) 2014, A PATIENT OF UNKNOWN GENDER AND AGE PRESENTED FOR AN ENDOVENOUS LASER PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED COMPLICATIONS OR DEVICE MALFUNCTIONS. THE TREATING PHYSICIAN REPORTED A PULSING THROUGH THE FIBER DURING THE TREATMENT. POST-PROCEDURE, THE TREATING PHYSICIAN REPORTED THE PATIENT HAD EXPERIENCED A HIGH LEVEL OF PAIN. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED LASER GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368803 VENACURE1470 VENACURE 1470 LASER GEX ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1