BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE

    MDR report key: 634838 · Received September 15, 2005

    Report

    Report Number
    3002648230-2005-00006
    Event Type
    Injury
    Date Received
    September 15, 2005
    Date of Event
    August 16, 2005
    Report Date
    September 15, 2005
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH INAPPROPRIATE SINUS TACHYCARDIA, WHO FAILED RADIOFREQUENCY ABLATION ONE MONTH PRIOR, HAD EPICARDIAL MAPPING AND CRYOABLATION WITH PHRENIC NERVE PACING COVERAGE AND PROCEDURAL OBSERVATION OF NORMAL DIAPHRAGMATIC MOTION. THREE DAYS LATER AT DISCHARGE, PATIENT WAS FOUND TO HAVE DECREASED MOVEMENT OF THE RIGHT HEMIDIAPHRAGM AND WAS DISCHARGED ON BREATHING EXERCISES AND WILL BE MONITORED AS AN OUTPATIENT. THIS EVENT CONSTITUTE A SERIOUS INJURY MANIFESTED 3 DAYS AFTER TISSUE ABLATION IN REGION OF AFFECTED NERVE AND THE EVENT PERSISTED AT THE TIME OF DISCHARGE. THIS EVENT IS A KNOWN COMPLICATION OF THE CRYOPROCEDURE WHEN CONDUCTED ADJACENT TO THE PHRENIC NERVE. THE DEVICE DID NOT MALFUNCTION BUT ITS CONTRIBUTION TO THIS EVENT CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE CARDIOVASCULAR DEVICE (CRYOCATHETER) NFC CRYOCATH TECHNOLOGIES, INC. 229F5 40914

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other