BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH 7F, 1304-CP-7-25-L-AB (USA)

    MDR report key: 1934265 · Received November 24, 2010

    Report

    Report Number
    2030404-2010-00241
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A F/U REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING AN ATRIAL FIBRILLATION ABLATION USING A COOL PATH CATHETER, A TEMP ALARM SOUNDED ABOUT 30 MINUTES INTO THE PROCEDURE. THE PHYSICIAN CHECKED THE CATHETER AND NOTICED FLUID DRIPPING FROM THE HANDLE. THE CATHETER WAS EXCHANGED FOR A NEW ONE AND THE PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-L-AB (USA) NONE OAD ST JUDE MEDICAL, IRVINE 84309 3208123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK