BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCOBIONICS SYSTEM

    MDR report key: 1713287 · Received June 3, 2010

    Report

    Report Number
    1319211-2010-00029
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    February 9, 2009
    Report Date
    June 4, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT WAS NOT FILED WITHIN THE 30 DAYS DUE TO THE RISK ANALYSIS THAT STATED, "IT IS THE OPINION OF MEDICAL AFFAIRS THAT OCCASIONAL VENTRICULAR ARRHYTHMIAS ARE NOT UNEXPECTED USING IRE AND WERE OCCASIONALLY SEEN IN PRECLINICAL ANIMAL STUDIES. IT MUST BE REMEMBERED THAT IRE REQUIRES GENERAL ANESTHESIA AND ALL PATIENTS ARE CLOSELY MONITORED. MEDICAL INTERVENTION (LIDOCAINE ETC.) AND CARDIOVERSION INSTRUMENTATION ARE PRESENT AT THE BEDSIDE. FUTURE STUDIES WILL INCLUDE THE USE OF CARDIAC SYNCHRONIZATION SUCH THAT THE NANOKNIFE GENERATED ELECTRIC PULSES WILL BE DELIVERED DURING THE REFRACTORY PERIOD OF THE CARDIAC CYCLE; THUS DRAMATICALLY REDUCING THE INCIDENCE OF VENTRICULAR ARRHYTHMIAS. THE ORIGIN OF THE MILD HYPERKALEMIA IS UNK BUT MAY BE RELATED TO THE RELEASE OF INTRACELLULAR POTASSIUM DURING THE IRE ABLATION. THIS AE HAD MILD, TRANSIENT SYMPTOMS THAT RESOLVED QUICKLY AND WERE NOT CONSIDERED LIFE-THREATENING." AFTER FURTHER EVAL WE HAVE DETERMINED THAT ARRHYTHMIAS THAT OCCUR DURING THE IRE PROCEDURE ARE REPORTABLE EVENTS. CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE, ANGIODYNAMICS IS UNABLE TO CONDUCT A THOROUGH INVESTIGATION. THE EXACT CAUSE OF THE COMPLAINT IS UNK. THE OPERATION MANUAL INDICATES THAT ENERGY DELIVERED IN THE THORACIC CAVITY MIGHT TRIGGER ATRIAL OR VENTRICULAR FIBRILLATION. ENSURE THAT INTERVENTIONS (DEFIBRILLATOR, ETC.) APPROPRIATE DEALING WITH FOR CARDIAC ARRHYTHMIAS ARE READILY AVAILABLE. THE REPORTED COMPLAINT COULD HAVE BEEN CAUSED FROM THE GENERAL ANESTHESIA, THE MUSCLE BLOCK, PATIENT CONDITION OR THE IRE PROCEDURE. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TREND. NO FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT WAS NOT SYNCHRONIZED AND DEVELOPED RUNS OF VENTRICULAR TACHYCARDIA DURING THE ACTIVATIONS AND STOPPED WHEN THE ACTIVATIONS STOPPED. THERE WAS A LOSS OF ARTERIAL BLOOD PRESSURE DURING THE ACTIVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOBIONICS SYSTEM NANOKNIFE IRE SINGLE ELECTRODE PROBE GEI ANGIODYNAMICS NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention