BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 6132621 · Received November 29, 2016

    Report

    Report Number
    3002648230-2016-00503
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK OF THE PATIENT BEING UNDER GENERAL ANESTHESIA WITHOUT FULL THERAPEUTIC EFFECT IS THE ADVERSE EVENT BEING REPORTED. THE DECISION TO ABORT THE PROCEDURE WITHOUT USE OF ALTERNATE THERAPY WAS BASED UPON THE MEDICAL JUDGMENT OF THE PHYSICIAN. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE PATIENT BEGAN TO COUGH SPONTANEOUSLY DUE TO A REDUCED GENERAL ANESTHESIA LEVEL, SHORTLY THEREAFTER; HEMOPTYSIS WAS OBSERVED IN THE ENDOTRACHEAL TUBE. THE CAUSE OF THE HEMOPTYSIS IS UNKNOWN. IT WAS NOTED THAT THE PATIENT¿S ACT (ACTIVATED CLOTTING TIME) READING WAS ¿OUT OF RANGE¿. THE PATIENT¿S AIRWAY WAS STABILIZED BY ANESTHESIA, THE PROCEDURE ABORTED, AND ANTICOAGULATION WAS REVERSED. THE PATIENT REMAINED INTUBATED AND A BRONCHOSCOPY WAS PERFORMED. THE INITIAL BRONCHOSCOPY SHOWED A SMALL AMOUNT OF BLOOD IN THE RIGHT LOWER LOBE OF THE LUNG. A REPEAT BRONCHOSCOPY THE NEXT MORNING WAS CLEAR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783060 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R