BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 4847603 · Received June 9, 2015

    Report

    Report Number
    MW5043088
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 9, 2015
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INTRA-OPERATIVE EVENT - SEVERE SYMPTOMATIC BRADYCARDIA RELATED TO USE OF THE NANOKNIFE SYSTEM FROM ANGIODYNAMICS FOR IRREVERSIBLE ELECTROPORATION WHICH HAS RECEIVED FDA CLEARANCE FOR THE SURGICAL ABLATION OF SOFT TISSUE [510(K) NUMBER: K080376]. TWO PROBES WERE PLACED IN THE LIVER LESION FOR ABLATION. A TEST RUN OF THE DEVICE WAS PERFORMED. IMMEDIATELY AFTER STARTING ABLATION THE PATIENT'S HEART RATE DROPPED TO THE LOW 20S AND HE BECAME HYPOTENSIVE TO SYSTOLIC PRESSURES IN THE 40S. THIS WAS TREATED WITH HALTING THE DEVICE AND ADMINISTERING EPINEPHRINE AND THE BLOOD PRESSURE INCREASED TO STABLE LEVELS APPROPRIATELY. NO POSTOPERATIVE EFFECTS OF THIS EVENT HAVE BEEN NOTED. THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369710 NANOKNIFE SYSTEM IRE - NANOKNIFE OAB ANGIODYNAMICS GENERATOR AND ELECTRODES

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening