BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER

    MDR report key: 9547126 · Received January 3, 2020

    Report

    Report Number
    3002648230-2020-00006
    Event Type
    Death
    Date Received
    January 3, 2020
    Date of Event
    January 1, 2019
    Report Date
    January 3, 2020
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. OF NOTE, MULTIPLE PATIENTS/MULTIPLE METHODS/MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS/METHODS/MANUFACTURERS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿CURRENT STATUS AND CLINICAL OUTCOMES OF ORAL ANTICOAGULANT DISCONTINUATION AFTER ABLATION FOR ATRIAL FIBRILLATION IN JAPAN. FINDINGS FROM THE AF FRONTIER ABLATION REGISTRY.¿ CIRCULATION JOURNAL. CIRC J 2019; 83: 2418 ¿ 2427. DOI: 10.1253/CIRCJ.CJ-19-0602. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATIONS WHILE USING A CRYOBALLOON ABLATION CATHETER: THERE WERE PATIENTS WHO DIED DURING THE FOLLOW UP PERIOD. THE DEATHS COMPRISED CARDIOVASCULAR DEATHS, STROKE-RELATED DEATHS, AND NON-CARDIOVASCULAR DEATHS. THERE IS NO INDICATION THAT THE DEATHS WERE DEVICE/PRODUCT RELATED. THE STATUS OF THE CATHETER IS UNKNOWN. OF NOTE, MULTIPLE PATIENTS/MULTIPLE METHODS/MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS/MANUFACTURERS. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10090 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 63 YR Death| H| L| R