BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBLE

    MDR report key: 3003838 · Received March 12, 2013

    Report

    Report Number
    1056436-2013-00013
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    September 6, 2012
    Report Date
    February 12, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K010060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF A DEVICE MALFUNCTION OR A PRODUCT PROBLEM. THIS REPORT IS NOT BEING SUBMITTED FOR A PRODUCT PROBLEM BUT RATHER TO REPORT THE PT'S DEMISE DURING THE PROCEDURE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION OR PRODUCT PROBLEM. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE PACKAGING AND COMPONENT LOTS OBTAINED THROUGH A SHIP HISTORY REPORT FOR ANY DEVIATION. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECS. THE DISPOSABLE ANGIODYNAMICS DEVICE USED DURING THE PROCEDURE WAS DISPOSED OF BY THE USER POST PROCEDURE AND IS NOT AVAILABLE TO BE RETURNED. ATTEMPTS ARE BEING MADE BY THE FIRM TO OBTAIN FURTHER INFO REGARDING THE EVENT INCLUDING BUT NO LIMITED TO THE CAUSE OF DEATH. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVAL WILL BE SENT VIA A F/U MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER ON (B)(6) 2013, A PT OF UNK AGE PRESENTED FOR A RF LUNG LESION ABLATION PROCEDURE ON (B)(6) 2012. THE PT APPEARED HEALTHY AT THE TIME OF THE ABLATION. APPROX MIDWAY INTO THE TREATMENT THE PT ASPIRATED A "LOT OF BLOOD" AND THE CLINICIAN ABORTED THE CASE. THE PT STARTED TO DECOMPENSATE AND THE CODE TEAM WAS CALLED. IT WAS REPORTED THAT THE PT EXPIRED ON (B)(6) 2012. ANGIODYNAMICS WAS NOTIFIED OF THE DEATH ON (B)(6) 2013. THERE WAS NO ALLEGATION OF MALFUNCTION WITH THE STARBURST XLIE SEMI-FLEX DEVICE OR THE 1500X GENERATOR USED DURING THE PROCEDURE. THE DISPOSABLE PROBE USED DURING THE CASE WAS DISCARDED POST PROCEDURE AND WILL NOT BE RETURNED TO ANGIODYNAMICS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103505 STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBLE RADIOFREQUENCY ABLATION DEVICE GEI ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death