BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH 7F, 1304-CP-7-25-L-AB (USA)

    MDR report key: 1961663 · Received December 28, 2010

    Report

    Report Number
    2030404-2010-00286
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 12/28/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A HANDLE LEAK. AFTER APPROXIMATELY 90 MINUTES OF USE, SALINE STARTED LEAKING FROM THE BACK OF THE HANDLE. THE CATHETER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE COMPLETED WITHOUT ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-L-AB (USA) NONE OAD ST. JUDE MEDICAL, IRVINE 84309 3219521

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK