BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3003846 · Received March 14, 2013

    Report

    Report Number
    3002648230-2013-00037
    Event Type
    Death
    Date Received
    March 14, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 24, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. BIN FILES WERE ANALYZED AND DO NOT SHOW ANY SYSTEM NOTICE OR ISSUES FOR THE DATE OF THE PROCEDURE. BIN FILES SHOW THAT AT LEAST 20 INJECTIONS WERE PERFORMED WITH THE CATHETER WITH LOWEST TEMPERATURE OF -61 DEGREES C AT THE 6TH INJECTION. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THIS REPORT WILL BE RECORDED AND TRENDED.

    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 ON (B)(6) 2013. THE PATIENT COMPLAINED OF FLU-LIKE SYMPTOMS AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013. MANY TESTS WERE PERFORMED INCLUDING A CT AND MRI. THE PATIENT LOST CONSCIOUSNESS WHILE SHOWERING AT THE HOSPITAL. AFTER FURTHER TESTS, THE PHYSICIANS FOUND A VEGETATION / THROMBUS IN THE LEFT INFERIOR PULMONARY VEIN. THE THROMBUS THEN TRAVELED TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AND THE PATIENT DIED. AN AUTOPSY WAS PERFORMED (B)(6) 2013 AND CONFIRMED THAT THE PATIENT HAD AN ESOPHAGEAL FISTULA. THERE WAS A DIME-SIZE HOLE IN THE ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107266 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Death