BEUDAMED
    FDA Adverse Event Death Summary report: N

    NANOKNIFE SINGLE ELECTRODE PROBE, 15CM

    MDR report key: 2192416 · Received July 6, 2011

    Report

    Report Number
    1319211-2011-00061
    Event Type
    Death
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NOT BEING SENT FOR A PRODUCT PROBLEM. THERE WAS NO ALLEGATION THAT THE DEVICE MALFUNCTIONED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THIS REPORT IS BEING SUBMITTED TO NOTIFY THE FDA THAT THE PT EXPIRED 10 DAYS POST PROCEDURE. IN THE OPINION OF THE PHYSICIAN WHO PERFORMED THE PROCEDURE, THE COMPLICATIONS THAT DEVELOPED WERE NOT NECESSARILY RELATED TO THE LEDC ABLATION, BUT RATHER THE ENTIRE PROCEDURE, INCLUDING PROLONGED GENERAL ANESTHESIA AND ENDOTRACHEAL INTUBATION. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) MALE PT PRESENTED FOR A NANOKNIFE LEDC ABLATION ON (B)(6) 2011. AS REPORTED ON (B)(6) 2011 BY THE PHYSICIAN WHO PERFORMED THE PROCEDURE, PT DEVELOPED PNEUMONIA WHICH REQUIRED RE-INTUBATION AT DAY 3 POST-PROCEDURE. THIS CONDITION WAS COMPLICATED BY ACUTE RENAL FAILURE AND BY ACUTE RESPIRATORY DISTRESS SYNDROME, EVENTUALLY LEADING TO THE PT'S DEMISE ONE WEEK LATER ON (B)(6) 2011. ALSO FURTHER COMPLICATED AT DAY 3 POST PROCEDURE BY EXACERBATION OF LEFT-SIDED PNEUMOTHORAX (WHICH WAS INITIALLY TINY, < 5 MM ON CT SCAN AT END OF PROCEDURE); THIS WAS SUCCESSFULLY TREATED BY CHEST TUBE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANOKNIFE SINGLE ELECTRODE PROBE, 15CM TISSUE ABLATION DEVICE GEI ANGIODYNAMICS NA NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death