BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCOBIONICS SYSTEM

    MDR report key: 1713288 · Received June 3, 2010

    Report

    Report Number
    1319211-2010-00028
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    February 9, 2009
    Report Date
    June 4, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    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 REPORTED COMPLAINT STATES A PATIENT CONDITION AND NOT A PRODUCT FAILURE. BASED ON THE REPORTED COMPLAINT, THE IRE SINGLE PROBE DEVICE FUNCTIONED PROPERLY. THE EXACT CAUSE OF THE COMPLAINT IS UNK. 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 TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN ARRHYTHMIA WHICH APPEARED AS A SERIES OF VENTRICULAR ECTOPICS WHICH PERSISTED FOR SEVERAL SECONDS AFTER THE IRE ACTIVATION. SHE ALSO DEVELOPED A MILD HYPOCALCAEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention