BEUDAMED
    FDA Adverse Event Other Summary report: N

    NANOKNIFE SINGLE ELECTRODE PROBE, 15CM

    MDR report key: 2071026 · Received April 19, 2011

    Report

    Report Number
    1319211-2011-00035
    Event Type
    Other
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NOT BEING SENT FOR A PRODUCT PROBLEM. THERE WAS NO ALLEGATION THAT THE DEVICE MALFUNCTIONED. THIS REPORT IS BEING SUBMITTED TO NOTIFY THE FDA THAT MEDICAL INTERVENTION WAS REQUIRED DURING THE PROCEDURE. IT WAS UNCLEAR IF THE ELEVATION IN BLOOD PRESSURE WAS FROM PAIN DURING ENERGY DELIVERY OR IF THE TUMOR HAD RELEASED SOME CHEMICALS DURING THE ABLATION THAT COULD HAVE EFFECTED THE PT'S BLOOD PRESSURE. THE PHYSICIAN WHO PERFORMED THE PROCEDURE THEORIZED THAT PERHAPS THE TUMOR HAD SOME NEUROENDOCRINE COMPONENT TO IT. THE PHYSICIAN NOTED THAT THE PROBES OR THE ABLATION ZONE WERE NOT NEAR THE ADRENAL GLANDS OR ANY OTHER CONCERNING STRUCTURES. A POST SCAN WAS PERFORMED WHICH SHOWED NO EVIDENCE OF INJURY TO SURROUNDING STRUCTURES. (B)(4).

    Description of Event or Problem · 1

    THE PROCEDURE CONSISTED OF A NANOKNIFE ABLATION OF A LARGE ABDOMINAL WALL MASS. THE PT TOLERATED THE FIRST HALF OF THE PROCEDURE WELL WITH NO CHANGES IN VITAL SIGNS. THEN THREE OF THE PROBES WERE RE-POSITIONED TO PERFORM AN OVERLAP ABLATION. THE ABLATION WAS STARTED AND THE PT'S BLOOD PRESSURE BEGAN TO RISE. THE PRESSURE REACHED A PEAK OF APPROX 230/150. THE BASELINE BEFORE THE PROCEDURE WAS AROUND 120 SYSTOLIC. ANESTHESIA WAS UNABLE TO LOWER THE PRESSURE AFTER ADMINISTERING MEDICATION. THE ABLATION WAS ABORTED AND THE PT'S PRESSURE IMMEDIATELY RETURNED TO BASELINE. THE PT'S HEART RATE NEVER CHANGED DURING THE ENTIRE PROCEDURE AT 55-60 BEATS PER MINUTE. THE PT AWOKE FROM ANESTHESIA AND HIS BLOOD PRESSURE HAD RETURNED TO NORMAL. NO HARM OR INJURY WAS REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANOKNIFE SINGLE ELECTRODE PROBE, 15CM TISSUE ABLATION DEVICE GEI ANGIODYNAMICS, INC. NA NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention