BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5400263 · Received January 30, 2016

    Report

    Report Number
    3006451981-2016-00106
    Event Type
    Malfunction
    Date Received
    January 30, 2016
    Date of Event
    April 20, 2015
    Report Date
    April 26, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE # : (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 THAT DURING A CT-CONTROLLED (COMPUTER TOMOGRAPH) ABLATION THE GENERATOR TURNED OFF AFTER ABOUT 10 SEC. THE DISPLAY OF THE GENERATOR SHOWED THAT THE TEMPERATURE EXTREME VALUE IN THE ANTENNA WAS PASSED OVER. CORRECT FUNCTION OF COOLING WAS CHECKED AND THE RESET BUTTON WAS PRESSED WITH NO FUNCTION. THE ANTENNA WAS UNDAMAGED - NO BEND. A NEW ANTENNA WAS USED AND THE PROCEDURE WAS FINISHED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59017 20CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LLC (SHANGHAI) S4FG006X

    Patients

    Seq Age Sex Outcome Treatment
    1