BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F IRRIGATED ABLATION CATHETER

    MDR report key: 1820044 · Received August 24, 2010

    Report

    Report Number
    2030404-2010-00102
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN EVALUATION HAS BEEN COMPLETED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 08/24/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4)2010.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ABLATION PROCEDURE, ISOLATION OF THE PULMONARY VEINS COULD NOT BE COMPLETED. THE CATHETER WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THERE WAS NO IRRIGATION TO THE TIP OF THE CATHETER DUE TO A SALINE LEAK FROM THE HANDLE. THE DEVICE WAS REPLACED AND THE PROCEDURE CONTINUED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F IRRIGATED ABLATION CATHETER COOL PATH ABLATION CATHETER OAD ST. JUDE MEDICAL 88067 K23642

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK