BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB

    MDR report key: 1900005 · Received October 22, 2010

    Report

    Report Number
    2030404-2010-00200
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 27, 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

    VISUAL AND FUNCTIONAL TESTING OF THE RETURNED CATHETER REVEALED NO ANOMALIES. THE CATHETER PASSED PRESSURE DROP TESTING AND LEAK TESTING. DURING ABLATION SIMULATION THE CATHETER DELIVERED SALINE AS EXPECTED. THE COMPLAINT OF A LEAKING HANDLE COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE HANDLE OF THE CATHETER LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83565 K28317

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK