BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIC FRONT ADVANCE

    MDR report key: 3012708 · Received March 12, 2013

    Report

    Report Number
    3012708
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE ABLATION PROCEDURE, THE STEERING CABLE WITHIN THE CATHETER SNAPPED ALLOWING FOR ONLY ONE-SIDED CATHETER FLEXION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CRYOABLATION FOR ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104430 ARTIC FRONT ADVANCE CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A DQY MEDTRONIC, INC 2AF284 29298

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR