BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 2682793 · Received July 31, 2012

    Report

    Report Number
    1319211-2012-00063
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    OAB
    PMA / PMN Number
    K080202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NANOKNIFE SYSTEM INCLUDES PROBES THAT ARE SINGLE USE AND DISPOSABLE. NO COMPONENTS OF THE SYSTEM WAS RETURNED TO ANGIODYNAMICS, THEREFORE A DEVICE EVAL WAS NOT CONDUCTED IN REGARD TO THIS EVENT. DURING A REVIEW OF QUALITY INSPECTION AND MFG DOCUMENTS IT WAS DETERMINED THAT THE DEVICE MET ALL SPECS AND QUALITY REQUIREMENTS. A REVIEW OF THE HARDWARE SERVICE DATABASE FOUND NO SERVICE ORDERS FOR THE GENERATOR AROUND THE TIME OF ISSUE. THE REPORTED HYPERTENSION WAS EXPECTED DUE TO THE INTENDED PLACEMENT OF THE PROBES, WHERE TWO PROBE NEEDLES WERE VERY CLOSE TO THE LEFT ADRENAL GLAND. THIS EVENT WILL BE TRENDED AND MONITORED BY ANGIODYNAMICS COMPLAINT HANDLING DEPARTMENT. INTERNAL COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    A (B)(6) PT UNDERWENT NANOKNIFE IRE TREATMENT FOR PANCREATIC CANCER ON (B)(6) 2010. DURING THE TREATMENT, HYPERTENSION WAS REPORTED DURING IRE PULSE DELIVERY. TWO OF THE PROBES WERE CLOSE TO THE LEFT ADRENAL GLAND THEREFORE HYPERTENSION WAS EXPECTED DURING IRE PULSE DELIVERY. PT BLOOD PRESSURE WAS MONITORED DURING IRE PULSE DELIVERY, PT WAS STABLE, NO INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other