BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5387022 · Received January 22, 2016

    Report

    Report Number
    3006451981-2016-00072
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    October 27, 2015
    Report Date
    October 27, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS PART OF A RETROSPECTIVE REVIEW AS PART OF A REMEDIATION RELATED TO CAPA (B)(4) ALTHOUGH NO SAMPLE WAS RETURNED IN THIS CASE, IN OTHER SIMILAR INCIDENTS, COVIDIEN¿S INVESTIGATION IDENTIFIED TWO POSSIBLE ROOT CAUSES FOR THE DEVICE FAILURE. THE HUB DIVIDER SHIFTING DISTALLY WITHIN THE HUB OR THE INFLOW TUBE EXPANDING OR RUPTURING. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. A SPACER WAS ADDED TO PREVENT THE HUB FROM SHIFTING. ADDITIONALLY, THE INFLOW TUBE MATERIAL WAS REVISED. THE NEW INFLOW TUBE IS MADE FROM POLYIMIDE, WHICH RESULTS IN INFLOW TUBES WITH MORE STRENGTH REDUCING THE LIKELIHOOD OF EXPANSION OR RUPTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE EMPRINT CA15L1 ANTENNA WAS USED TO ABLATE A COLORECTAL LIVER METS IN AN OPEN SURGICAL FIELD. THE 1ST ABLATION OF 2.5 MINS AT 100 WATTS WORKED PERFECTLY. THE ANTENNA WAS REMOVED AND RE-POSITIONED INTO A 2ND METS (THE GENERATOR AND PUMP WERE LEFT ON DURING THE RE-POSITIONING). THE WATTS WERE RESET TO 100 AND TIME TO 2 MINS, THE ABLATION COMMENCED AND AFTER 3 SECS A TEMP WARNING ALARM CAME ON AND THE PROCEDURE STOPPED. WE RESET AND TRIED AGAIN 4 MORE TIMES WITH THE SAME OUTCOME. THE PUMP WAS STOPPED AND RESET THE RESERVOIR TWICE AND NOTICED A POOR FLOW AND STILL GOT TEMPERATURE ALARM. THE SALINE BAG WAS SWAPPED FOR A NEW ONE AND RE-SET, AGAIN WITH THE SAME ALARM AFTER 2-3 SECONDS. A NEW ANTENNA WAS OPENED AND WE RESTARTED THE PROCEDURE, THIS TIME IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44674 15CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LLC (SHANGHAI) S5GG009X

    Patients

    Seq Age Sex Outcome Treatment
    1