BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 5314443 · Received December 21, 2015

    Report

    Report Number
    3002648230-2015-00467
    Event Type
    Injury
    Date Received
    December 21, 2015
    Date of Event
    January 1, 2014
    Report Date
    November 29, 2015
    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

    MEDTRONIC CRYOCATH 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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. NO FURTHER DETAILS WERE AVAILABLE. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE REFERENCED IN THE ARTICLE. THE BASELINE CHARACTERISTICS OF THE PATIENTS REFERENCED IN THE ARTICLE IS GENDER/AGE IS MALE/66 YEARS OLD. 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. REFERENCED ARTICLE: ¿A COMPARISON OF BLEEDING COMPLICATIONS BETWEEN WARFARIN, DABIGATRAN, AND RIVAROXABAN IN PATIENTS UNDERGOING CRYOBALLOON ABLATION.¿ J INTERV CARD ELECTROPHYSIOL. 2014. 41:231¿236. DOI 10.1007/S10840-014-9948-1. (B)(4)

    Description of Event or Problem · 1

    "A COMPARISON OF BLEEDING COMPLICATIONS BETWEEN WARFARIN, DABIGATRAN, AND RIVAROXABAN IN PATIENTS UNDERGOING CRYOBALLOON ABLATION." J INTERV CARD ELECTROPHYSIOL. 2014. 41:231-236. DOI 10.1007/S10840-014-9948-1. THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATIONS: SIX PATIENTS WITH A REPORTED HEMATOMAS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839495 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 00067 YR Hospitalization| R