BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5387035 · Received January 22, 2016

    Report

    Report Number
    3006451981-2016-00075
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    November 5, 2015
    Report Date
    November 5, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    NEY
    UDI-DI
    10884521189539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS PART OF A RETROSPECTIVE REVIEW AS PART OF A REMEDIATION RELATED TO (B)(4). 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 THAT DURING A PERCUTANEOUS ABLATION THE ANTENNA WAS PLACED INSIDE THE TUMOR AND THE WATER FLOW WAS GOOD FOR 2 CYCLES AT 100 WATT AROUND 6 MINUTES. AT THE THIRD CYCLE THE TEMP ALERT WAS ON BUT THE FLOW WAS STILL GOOD. THE WATER BAG WAS FEELING WARM. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH ANOTHER EMPRINT ANTENNA. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44417 15CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LLC (SHANGHAI) S5HG001X 10884521189539

    Patients

    Seq Age Sex Outcome Treatment
    1