BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5384325 · Received January 21, 2016

    Report

    Report Number
    3006451981-2016-00041
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Report Date
    September 21, 2015
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 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 PROCEDURE, THE DEVICE TRIGGERED A HIGH TEMPERATURE ALERT AFTER THREE MINUTES OF USE AND STOPPED WORKING. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40969 30CM PERCUTANEOUS ANTENNA X1 30CM PERCUTANEOUS ANTENNA X1 NEY COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN CA30L1 S4LG005X

    Patients

    Seq Age Sex Outcome Treatment
    1