BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 2683309 · Received July 31, 2012

    Report

    Report Number
    1319211-2012-00156
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    April 22, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    OAB
    PMA / PMN Number
    K080202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NANOKNIFE SYSTEM INCLUDES PROBES THAT ARE SINGLE USE AND DISPOSABLE. NO COMPONENT OF THE SYSTEM WAS RETURNED TO ANGIODYNAMICS, THEREFORE A DEVICE EVALUATION WAS NOT CONDUCTED IN REGARD TO THIS EVENT. DURING A REVIEW OF QUALITY INSPECTION AND MANUFACTURING DOCUMENTS IT WAS DETERMINED THAT THE DEVICE MET ALL SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE HARDWARE SERVICE DATABASE FOUND NO SERVICE ORDERS FOR THE GENERATOR AROUND THE TIME OF ISSUE. THE CAUSE OF THE HYPERTENSION COULD NOT BE DETERMINED. THE COMPLAINT FILE STATES THAT THE ANESTHESIA CRNA EXPECTED THIS OCCURRENCE, BUT DID NOT DESCRIBE THE REASON. THIS EVENT WILL BE TRENDED AND MONITORED BY ANGIODYNAMICS COMPLAINT HANDLING DEPARTMENT. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) PATIENT UNDERWENT NANOKNIFE IRE TREATMENT FOR LIVER CANCER ON (B)(6) 2011. DURING THE TREATMENT AN EVENT WAS REPORTED FOR HYPERTENSION. PATIENT'S BASELINE BLOOD PRESSURE WAS 131/72. DURING THE FIRST TREATMENT, AT ITS PEAK, BP WAS 202/100. THAT TREATMENT WAS ABORTED WITH 66% OF ABLATION COMPLETED TO CONTROL THE PATIENT'S BLOOD PRESSURE. THE PATIENT RECEIVED LABETALOL, FENTANYL, AND MORPHINE. THE BLOOD PRESSURE WAS BROUGHT BACK TO NORMAL RANGE AND THE TREATMENT WAS COMPLETED. THE PATIENT VITALS WERE NORMAL IMMEDIATELY AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS, INC. HVP-01

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention