BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    15CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5414077 · Received February 5, 2016

    Report

    Report Number
    3006451981-2016-00119
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    October 1, 2015
    Report Date
    October 5, 2015
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 02/05/2016. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MACHINE STOPPED WORKING DURING THE ABLATION PROCEDURE. THE PROBLEM COULD NOT BE RECTIFIED. A COO-TIP SYSTEM WAS USED TO COMPLETE THE PROCEDURE WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71128 15CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LLC (SHANGHAI) CA15L1 S5GG009X

    Patients

    Seq Age Sex Outcome Treatment
    1