BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 11007812 · Received December 15, 2020

    Report

    Report Number
    2182208-2020-03283
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 14, 2019
    Report Date
    December 14, 2020
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT THE UNIQUE PRODUCT SERIAL NUMBERS, A ONE TO ONE CORRELATION COULD NOT BE MADE, THE MANUFACTURED DATE CANNOT BE ESTABLISHED, AND IT IS UNKNOWN IF THIS WAS PREVIOUSLY REPORTED. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE. THE BASELINE GENDER/AGE/RACE CHARACTERISTIC IS MALE/(B)(6) YEARS/CAUCASIAN. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: A RANDOMIZED COMPARISON OF MANUAL PRESSURE VERSUS FIGURE-OF-EIGHT SUTURE FOR HEMOSTASIS AFTER CRYOBALLOON ABLATION FOR ATRIAL FIBRILLATION. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 2019 DEC;30(12):2806-2810 DOI: 10.1111/JCE.14252. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING A CRYOABLATION BALLOON. THE AUTHORS DESCRIBED CASES WHERE THREE PATIENTS DEVELOPED A MINOR HEMATOMA. THERE WAS NO INDICATION THAT INTERVENTION WAS REQUIRED. ONE PATIENT DEVELOPED A PSEUDOANEURYSM, WHICH WAS DIAGNOSED THIRTY DAYS POST ABLATION. THE PATIENT WAS MANAGED WITH COMPRESSION AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE DISPOSITION OF THE PRODUCTS IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472377 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC, INC. 2AF234

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention