BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1881739 · Received October 11, 2010

    Report

    Report Number
    2030404-2010-00176
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER IS CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. THE SALINE ENTERED THE CATHETER CONNECTER AND CREATED A CONDUCTOR WIRE SHORT WITH THE THERMOCOUPLE RESULTING IN THE REPORTED GENERATOR ALARM. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. DATE REPORT SUBMITTED TO FDA BY MFR: 10/11/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AFTER A FEW APPLICATIONS OF RF, THE GENERATOR SHOWED A HIGH TEMPERATURE ALARM. THE CATHETER WAS NOTED TO BE LEAKING FROM THE HANDLE. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER AND THE PROCEDURE CONTINUED WITHOUT CONSEQUENCES TO THE PT.

    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 83562 K27419

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK