BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYO CATHETER FREEZOR XTRA 3

    MDR report key: 1222763 · Received October 26, 2008

    Report

    Report Number
    1222763
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    August 6, 2008
    Report Date
    October 26, 2008
    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

    HIGH REFRIGERANT ERROR MESSAGE. EXCHANGED CATHETER AND PROBLEM WAS SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO CATHETER FREEZOR XTRA 3 CATHETER, CRYOABLATION, CARDIAC NFC CRYOCATH TECHNOLOGIES INC NA 02547

    Patients

    Seq Age Sex Outcome Treatment
    1 *