BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTLIGHT

    MDR report key: 16101804 · Received January 5, 2023

    Report

    Report Number
    16101804
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 13, 2022
    Report Date
    December 22, 2022
    Manufacturer
    CARDIOFOCUS, INC
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ENDOSCOPE DEVELOPED BLURRY IMAGE WHILE INSERTED IN BODY. REMOVED INTACT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276070 HEARTLIGHT CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE CARDIOFOCUS, INC 18-5000 18869-01

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA Female