BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BMC RF CANNULA

    MDR report key: 2587235 · Received April 5, 2012

    Report

    Report Number
    9710452-2012-00001
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    March 7, 2012
    Report Date
    April 6, 2012
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    GXI
    PMA / PMN Number
    K972846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED FOR STOCK CODE PMF18-100-10CS, AND THE RECORDS DOCUMENT THAT THE PRODUCT MET MFG SPECIFICATIONS. REVIEW OF THE DATABASE IDENTIFIED NO OTHER COMPLAINTS RECEIVED REGARDING THIS FAILURE MODE. A PHOTO OF THE REPORTED DEVICE HAS BEEN RECEIVED THAT SHOWS AN ELECTRODE WITH GAPS IN THE INSULATION. IT IS NOT KNOWN WHAT CAUSED THESE GAPS, BUT IF THE GAPS WERE PRESENT PRIOR TO USE, THEY WOULD HAVE BEEN NOTICED. BASED ON THE LIMITED INFO AVAILABLE, THE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY ADDITIONAL RELEVANT INFO IS IDENTIFIED ONCE THE SAMPLE IS EVALUATED, THIS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 1

    IN A BIPOLAR MULTI-LEVEL STANDARD RADIOFREQUENCY (RF) DENERVATION PROCEDURE FOR THE SIJ USING THE STANDARD RADIOFREQUENCY PROBES, CANNULAS AND A BIPOLAR ADAPTOR, THE PARAMETERS SHOWED HIGH IMPEDANCE AND POWER, AND TEMP AROUND 60 DEGREES C. THE RF DELIVERY WAS STOPPED AND THE CANNULA FROM ONE LEVEL WAS REMOVED FOR REPOSITIONING. THE CANNULA, WHEN REMOVED, SHOWED MISSING INSULATION. LIKELY, THIS WAS THE PASSIVE ELECTRODE. A DIFFERENT CANNULA WAS USED FOR THE PROCEDURE, AND WAS REPOSITIONED. THE PROCEDURE WAS COMPLETED SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BMC RF CANNULA CANNULA GXI BAYLIS MEDICAL CO., INC. PMF18-100-10CS PFFD200210

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR