BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1860148 · Received September 21, 2010

    Report

    Report Number
    2030404-2010-00146
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 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

    INVESTIGATION 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. THIS LEAK CAUSED A SHORT IN THE THERMOCOUPLE, RESULTING IN THE REPORTED INCREASED TEMPS. 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 WHILE ATTEMPTING TO DELIVER RF DURING THE ABLATION PROCEDURE, THE TEMP READING WOULD NOT GO ANY LOWER THAN 70 DEGREES CELSIUS. BECAUSE OF THIS, ABLATION WAS NOT POSSIBLE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED 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 88067 K23139

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK