BEUDAMED
    FDA Adverse Event Other Summary report: N

    NANOKNIFE SINGLE ELECTRODE PROBE, 15CM

    MDR report key: 2110076 · Received May 19, 2011

    Report

    Report Number
    1319211-2011-00038
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    June 30, 2010
    Report Date
    May 19, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NOT BEING SENT FOR A PRODUCT PROBLEM. THERE WAS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THIS REPORT IS BEING SUBMITTED TO NOTIFY THE FDA THAT MEDICAL INTERVENTION WAS REQUIRED, IN THE FORM OF .5MG CARDENE IV (CA+ CHANNEL BLOCKER), DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. NO HARM OR INJURY WAS REPORTED TO THE PATIENT. THIS MEDWATCH IS BEING SUBMITTED LATE DUE TO A RETROSPECTIVE REVIEW OF CASE NOTES. (B)(4).

    Description of Event or Problem · 1

    DURING A LAPAROTOMY WITH ULTRASOUND GUIDED NANOKNIFE ABLATION, THE PATIENT'S BLOOD PRESSURE AT BASELINE WAS APPROXIMATELY 120. WITHIN THE FIRST MINUTE OF PULSE GENERATION, THE PATIENT'S BLOOD PRESSURE BEGAN TO INCREASE, INDICATING HYPERTENSION. WHEN BLOOD PRESSURE WAS NOTED AT 190/114, THE PHYSICIAN ADVISED THAT PULSE GENERATION BE SUSPENDED. THE ANESTHESIOLOGIST GAVE 0.5MG CARDENE IV (CA+ CHANNEL BLOCKER) AND PATIENT'S BLOOD PRESSURE BEGAN TO NORMALIZE WITHIN 90 SECONDS OF ADMINISTRATION. WITH THE PATIENT'S BLOOD PRESSURE AT 112/63, THE PHYSICIAN ELECTED TO RESTART PULSE GENERATION. THE PATIENT'S BLOOD PRESSURE BEGAN TO INCREASE AGAIN INTO THE 150'S DURING PULSE GENERATION AND A SECOND DOSE OF CARDENE 0.5MG IV WAS ADMINISTERED. THE PATIENT'S BLOOD PRESSURE THEN REMAINED STABLE THROUGHOUT THE REST OF CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. NO HARM OR INJURY WAS REPORTED TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention