BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2153722 · Received July 7, 2011

    Report

    Report Number
    3002648230-2011-00075
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER MARKETED IN THE US. THE RETURNED CATHETER WAS VISUALLY AND FUNCTIONALLY TESTED AND PASSED THE INSPECTION AS PER SPECIFICATION.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED IN (B)(6) USING THE ARCTIC FRONT CATHETER. THREE VEINS WERE ISOLATED WITHOUT PROBLEM. DURING THE FIRST APPLICATION IN THE FOURTH VEIN (RIPV), THE TEMPERATURE DROPPED FROM -40°C (30 SECONDS INTO THE APPLICATION) TO BELOW -90°C AND THE APPLICATION WAS STOPPED AT 42.2 SECONDS. THE PATIENT HAD CHEST PAIN AND THE PROCEDURE WAS STOPPED. AFTER THE PROCEDURE, AN ULTRASOUND EXAMINATION WAS DONE AND A HEMATOMA WAS FOUND AROUND THE ANTRUM OF THE RIGHT PULMONARY VEIN. ONE HOUR AFTER THE PROCEDURE, THE PATIENT DID NOT HAVE ANY MORE CHEST PAIN. ONE DAY AFTER THE PROCEDURE, A CT INVESTIGATION WAS DONE AND NO HEMATOMA WAS FOUND AROUND THE RIGHT PULMONARY VEIN. AFTER A FEW DAYS OF OBSERVATION, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITHOUT FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER OAE MEDTRONIC CRYOCATH LP 2AF231 05224

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization