BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2833896 · Received November 7, 2012

    Report

    Report Number
    2030404-2012-00286
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FINAL ANALYSIS OF THE COMPLAINT DEVICE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ABLATION PROCEDURE, WHILE USING A COOL PATH DUO ABLATION CATHETER, SALINE WAS NOTED TO BE LEAKING FROM THE "TAIL END" OF THE DEVICE. NO DAMAGE WAS NOTED TO THE IRRIGATION PORT OF THE DEVICE BUT AFTER PERFORMING SOME ABLATION THE PT'S BED WAS NOTED TO BE WET. THE PROCEDURE WAS CONTINUED WITH A CATHETER OF THE SAME MODEL NUMBER WITH NO CONSEQUENCES TO THE PT.

    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, INC. (AF-IRVINE) 83562 3662881

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR