BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR MAX SURGICAL CRYOABLATION DEVICE

    MDR report key: 703493 · Received April 24, 2006

    Report

    Report Number
    3002648230-2006-00003
    Event Type
    Injury
    Date Received
    April 24, 2006
    Date of Event
    March 21, 2006
    Report Date
    April 3, 2006
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BEEN TREATED FOR RVOT FIRST. THE PHYSICIAN WAS USING TWO DEVICES AT THE SAME TIME. ENSITE ARRAY DEVICE AND PRESZOR MAX SURGICAL DEVICE. THE ENSITE ARRAY DEVICE WAS NOT INFLATED ALL THE WAY, AT THE 5TH LESION. THE PHYSICIAN NOTICED A DROP OF PATIENT PRESSURE. THE PROCEDURE WAS STOPPED AND THE PATIENT CHECKED. THE ECHOGRAPHY SHOWED A SMALL PERFORATION, WHICH WAS SEALED BY ITSELF AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR MAX SURGICAL CRYOABLATION DEVICE CARDIOVASCULAR CRYOCATHETER NFC CRYOCATH TECHNOLOGIES, INC. 229F3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other