BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 1991074 · Received February 11, 2011

    Report

    Report Number
    3002648230-2011-00001
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC CRYOCATH, LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    DURING CRYOABLATION PROCEDURE USING ARCTIC FRONT CATHETER, WHILE ABLATING THE 4TH PULMONARY VEIN, THE CRYOCONSOLE SHOWED TWO SYSTEM NOTICE ERRORS (50005 AND 50006, SEE DESCRIPTION BELOW). THE PT EXPERIENCED ANGINA PECTORIS AND THE ECG SHOWED ST SEGMENT ELEVATION FOR APPROX 10 MINUTES. THE PROCEDURE WAS STOPPED. SYSTEM NOTICE 50005: THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. SYSTEM NOTICE 50006: THE SAFETY SYSTEM HAS DETECTED BLOOD IN THE CATHETER HANDLE, STOPPED THE INJECTION AND DISABLED THE VACUUM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011, AND WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH, LP 2AF281 31270-10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability