BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBLE

    MDR report key: 5647319 · Received May 11, 2016

    Report

    Report Number
    1056436-2016-00020
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 26, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K010060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFORMATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF "A STARBURST XLIE - THERE WAS SKIN BURN WHILE THE PROBE WAS INSERTED, 8 - 9 CM." IS CONFIRMED BASED ON THE PHOTOGRAPH PROVIDED BY THE CUSTOMER. AS THE REPORTED COMPLAINT SAMPLE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE LOT NUMBERS OBTAINED THROUGH THE SHR FOR THE PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS. A DEVICE HISTORY RECORDS SEARCH REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THIS DOES NOT APPEAR TO BE THE RESULT OF A MANUFACTURING FAILURE. NO CORRECTION IS REQUIRED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION AND A ROOT CAUSE FOR THIS EVENT IS INCONCLUSIVE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2016 VIA ANGIODYNAMICS SALES REPRESENTATIVE, "A STARBURST XLIE - THERE WAS SKIN BURN WHILE THE PROBE WAS INSERTED, 8 - 9 CM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301191 STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBLE RF PROBE GEI ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention