BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2151514 · Received June 21, 2011

    Report

    Report Number
    2030404-2011-00188
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    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

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LEAK FROM THE HANDLE OF THE COOL PATH DUO CATHETER DURING AN ABLATION PROCEDURE. THE PHYSICIAN WAS PERFORMING AN ABLATION PROCEDURE USING THE COOL PATH DUO CATHETER. THE GENERATOR POWER DROPPED TO 1-3 WATTS AFTER A COUPLE DOZEN RF THERAPY APPLICATIONS. THE CATHETER WAS THEN REMOVED FROM THE BODY AND EXAMINED REVEALING THE FLOW RATE WAS DECREASED AND THERE WAS A LEAK FROM THE HANDLE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    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 CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 88067 K27992

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR