BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1848930 · Received September 16, 2010

    Report

    Report Number
    2030404-2010-00135
    Event Type
    Other
    Date Received
    September 16, 2010
    Date of Event
    August 22, 2010
    Report Date
    August 22, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED NO ANOMALIES. THE ABLATION SIMULATION TEST CONFIRMED THE TEMPERATURE SYSTEM FUNCTIONED NORMALLY. THE CAUSE FOR REPORTED COAGULUM FORMATION ON THE ELECTRODES REMAINS UNK. DATE REPORT SUBMITTED TO FDA BY MFR: (B)(4) 2010. DATE THE INITIAL RPTR PROVIDED THE INFO TO THE MFR: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, THE CATHETER WAS INSERTED THROUGH A SHEATH INTO THE RIGHT ATRIAL ISTHMUS AND APPROX 3000 SECONDS OF ABLATION WAS ADMINISTERED. THE CATHETER AND SHEATH WERE REMOVED TOGETHER AND IT WAS NOTED THAT COAGULUM HAD FORMED ON ELECTRODES 2, 3 AND 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83563 K06481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK