BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4073225 · Received June 19, 2014

    Report

    Report Number
    2030404-2014-00063
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P1110016/S00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC ABLATION PROCEDURE USING A THERAPY COOL FLEX ABLATION CATHETER, THE IRRIGATION PORT LEAKED. DURING THE PROCEDURE, SALINE WAS NOTED TO BE LEAKING FROM THE IRRIGATION PORT TUBING OF THE THERAPY COOL FLEX ABLATION CATHETER. THE CATHETER WAS EXCHANGED TO FINISH THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360298 THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088015 4370462

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR