BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATLIGHT LASER BALLOON

    MDR report key: 17488508 · Received August 9, 2023

    Report

    Report Number
    MW5121207
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    March 17, 2023
    Report Date
    May 4, 2023
    Manufacturer
    CARDIOFOCUS, INC.
    Product Code
    OAE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CALLER THAT DURING AN AFIB PROCEDURE THE PATIENTS PHRENIC NERVE WAS DAMAGED BY THE CARDIO FOCUS LASER BALLOON. A SOUNDSTAR CATHETER WAS THE ONLY BWI PRODUCT BEING USED FOR THE PROCEDURE WAS WAS NOT INVOLVED IN THE INJURY. THE SOUNDSTAR CATHETER WAS DISPOSED OF. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013195 HEATLIGHT LASER BALLOON CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE CARDIOFOCUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown