BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEZOR XTRA 3

    MDR report key: 1311544 · Received January 24, 2009

    Report

    Report Number
    1311544
    Event Type
    Malfunction
    Date Received
    January 24, 2009
    Date of Event
    November 21, 2008
    Report Date
    January 24, 2009
    Manufacturer
    CRYOCATH TECHNOLOGIES INC.
    Product Code
    NFC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ERROR MESSAGE WHEN ATTEMPTING TO ABLATE. MESSAGE READ HIGH REFRIGERENT FLOW. REPLACED CATHETERS AND PROBLEM WAS RESOLVED. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR XTRA 3 CATHETER, ABLATION, CRYO NFC CRYOCATH TECHNOLOGIES INC. 227F3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR