BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1880914 · Received October 4, 2010

    Report

    Report Number
    2030404-2010-00171
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    ST JUDE MEDICAL, IRVINE
    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

    THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HANDLE OF THE CATHETER LEAKED NEAR THE JOINT BETWEEN THE HANDLE AND THE IRRIGATION PORT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS.

    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 88067 K31687

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK