BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB

    MDR report key: 2181260 · Received July 8, 2011

    Report

    Report Number
    2030404-2011-00202
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT REMAINS UNK. EVAL AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING A COOL FLEX CATHETER TO PERFORM AN ABLATION PROCEDURE, LEAKING WAS NOTED FROM THE HANDLE OF THE CATHETER. UPON INSPECTION, IT WAS NOTED THE IRRIGATION PORT ON THE CATHETER WAS BROKEN. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST JUDE MEDICAL, IRVINE 88015 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1