BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLPATH DUO 7F, 1304-CP2-7-1.5(5)2-L1-TE4BE1AB-CN

    MDR report key: 1860131 · Received September 21, 2010

    Report

    Report Number
    2030404-2010-00145
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THERE WAS NO ISSUE RELATED TO COMPLAINT DURING MFG PROCESS. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A AF ABLATION PROCEDURE, CATHETER WAS LOSING INFUSION SOLUTION FROM THE HANDLE. THE CATHETER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLPATH DUO 7F, 1304-CP2-7-1.5(5)2-L1-TE4BE1AB-CN NONE OAD ST JUDE MEDICAL, IRVINE 88022 K18791

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR