BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1842616 · Received September 1, 2010

    Report

    Report Number
    2030404-2010-00113
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED CATHETER CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRM THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS HANDLE LEAKS IN THIS CATHETER. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 09/01/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE POWER DROPPED TO 1W AND THE TEMPERATURE OF THE CATHETER TIP REACHED ITS MAXIMUM ALLOWED DUE TO A LEAK IN THE CATHETER HANDLE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.

    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 NONE OAD ST. JUDE MEDICAL, IRVINE 83562 K25231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK