BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5385049 · Received January 22, 2016

    Report

    Report Number
    3006451981-2016-00052
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Report Date
    July 29, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(6) 2016. THIS COMPLAINT IS PART OF A RETROSPECTIVE REVIEW AS PART OF A REMEDIATION RELATED TO CAPA (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.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(4). DATE OF INITIAL REPORT: (B)(6) 2016. DATE OF FOLLOW-UP REPORT: (B)(6) 2016. THIS REPORT IS BEING FILED AS A CORRECTION TO THE INITIAL REPORT SUBMITTED ON (B)(6) 2016. THE INITIAL SUBMISSION MISTAKENLY REPORTED THE FAILURE AS PART OF A RETROSPECTIVE REVIEW RELATED TO CAPA2015-009106. EVALUATION OF THE INCIDENT SAMPLE CONFIRMED THE REPORTED FAILURE OF A TEMPERATURE ALERT. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE UNDETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GENERATOR GAVE A TEMPERATURE ALARM AFTER POSITIONING OF THE ANTENNA. THE COOLING SYSTEM AND CONNECTIONS CABLES WERE CHECKED AND THE GENERATOR WAS RESET BUT ONLY WHEN A NEW DEVICE WAS USED THE PROBLEM CORRECTED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43610 15CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LLC (SHANGHAI) CA15L1 S5BG001RTX

    Patients

    Seq Age Sex Outcome Treatment
    1