BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICURE

    MDR report key: 3143276 · Received April 2, 2013

    Report

    Report Number
    3143276
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ATRICURE
    Product Code
    MNB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPARENT FROSTBITE TYPE OF BURN FROM CRYO CONNECTOR. THE WHITE PLASTIC CONNECTOR OF CRYOPROBE WAS FOUND TO BE VERY COLD WHEN NOT IN USE DURING SURGERY. THERE WERE 2 UNFOLDED TOWELS BETWEEN THE CONNECTOR AND THE PT'S THIGH, W/TOWELS OVER IT, AND MOIST LAP SPONGES WERE OVER THEM. THE TEMPERATURE READING ON PROBE WAS 10 DEGREES CELSIUS. AFFECTED AREA WAS 6X3 CM, W/WHITENED CENTER AND MEDIUM RED EDGES, CHANGED TO DARK RED IN CENTER AND LIGHTER RED AFTER 5 MINUTES AND APPLYING WARM SALINE. CRYOPROBE MACHINE IS ATRICURE FRIGIONICS CCS200, SERIAL (B)(4). ARTICURE CRYOICE 10CM ABLATION PROBE LOT #43047. CRYO PROBE LAST USED PRIOR TO EVENT AT 1230. MACHINE WAS SWITCHED TO DEFROST ON POSITION ON SYSTEM II ORANGE SIDE IMMEDIATELY AFTER THAT USE. CRYO PROBE WILL BE SAVED AND PACKAGING. WE NOTED THAT AFTER THE PROBE WAS UNCOVERED THE TEMPERATURE OF IT WENT UP TO 15 DEGREES CELSIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135433 ATRICURE FRIGIONICS CCS202, CRYOICE ABLATION PROBE MNB ATRICURE CCS 202 PROBE 43047

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other