BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOFLEX

    MDR report key: 2383174 · Received December 20, 2011

    Report

    Report Number
    2134151-2011-00020
    Event Type
    Injury
    Date Received
    December 20, 2011
    Report Date
    November 21, 2011
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    OCL
    PMA / PMN Number
    K053436 
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. REVIEW OF LITERATURE FOUND NO SIMILAR REPORTS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE "CORONARY ARTERY SPASM AFTER CRYO MAZE III PROCEDURE" IN THE SOCIETY OF THORACIC SURGEONS (2011:92:1884-7) THAT A PATIENT HAD RIGHT CORONARY ARTERY SPASM DEVELOP AFTER THE CRYO MAZE III PROCEDURE USING AN ARGON-BASED CRYOABLATION SYSTEM WITH PROBE APPLICATION FOR A DURATION OF 120 SECONDS AT _100 DEGREES C. THE SPASM WAS REVERSED WITH INTRACORONARY NITROGLYCERIN WITH NO ADVERSE PATIENT EFFECTS. THE REGION OF SPASM SUGGESTED IT WAS A CONSEQUENCE OF PROXIMITY OF THE RIGHT CORONARY ARTERY TO THE RIGHT ATRIAL ABLATION LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOFLEX SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE OCL MEDTRONIC ATS MEDICAL 60SF2-002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention