BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30CM PERCUTANEOUS ANTENNA X1

    MDR report key: 5432049 · Received February 11, 2016

    Report

    Report Number
    3006451981-2016-00127
    Event Type
    Malfunction
    Date Received
    February 11, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 14, 2016
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED SAMPLE CONFIRMED THE REPORTED FAILURE. 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 LIVER ABLATION CASE, THEY WERE UNABLE TO RECOVER FROM A HIGH TEMP ALERT WITH 2:53 LEFT TO GO DURING A 10:00 MINUTE ABLATION AT 100W. THEY REPLACED THE NON-FUNCTIONING ANTENNA WITH NEW ANTENNA TO COMPLETE THE CASE WITHOUT ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88560 30CM PERCUTANEOUS ANTENNA X1 ABLATION ANTENNA NEY COVIDIEN LLC (SHANGHAI) CA30L1 S5LG009X

    Patients

    Seq Age Sex Outcome Treatment
    1