BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT ADVANCE PRO

    MDR report key: 11452989 · Received March 10, 2021

    Report

    Report Number
    11452989
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 17, 2021
    Report Date
    March 5, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OAE
    UDI-DI
    00763000245436
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT BALLOON WOULD NOT ADVANCE INTO SHEATH. NEW BALLOON OPENED W/O AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352942 ARCTIC FRONT ADVANCE PRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC, INC. AFAPRO28 13408 00763000245436

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA