BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5 (5)2-M-TE4BE1AB

    MDR report key: 1883222 · Received October 20, 2010

    Report

    Report Number
    2030404-2010-00196
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT DESCRIPTION OF "TEMPERATURE BEGAN TO RISE, THE RF POWER DECREASED AND A COMMUNICATION ERROR OCCURRED." DID NOT MEET ADVERSE EVENT REPORTING CRITERIA. THE INVESTIGATION FINDINGS MAKE THIS EVENT REPORTABLE. INVESTIGATION OF THE RETURNED DEVICE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. THE LEAK CAUSED A CONDUCTOR WIRE SHORT IN THE THERMOCOUPLE WHICH RESULTED IN THE ERROR MESSAGE ON THE GENERATOR. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    EVAL OF A CATHETER RETURNED FOR TEMPERATURE ERROR READINGS ON THE GENERATOR REVEALED A HANDLE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5 (5)2-M-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 88067 K23472

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK