BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM

    MDR report key: 17694031 · Received September 5, 2023

    Report

    Report Number
    MW5145264
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    August 28, 2023
    Report Date
    September 1, 2023
    Manufacturer
    CARDIOFOCUS, INC.
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING A CARDIOFOCUS LASER BALLOON ATRIAL FIBRILLATION ABLATION, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT RESULTED IN PERICARDIOCENTESIS AND ULTIMATELY A SURGICAL INTERVENTION BY A CARDIOTHORACIC SURGEON. THE PHYSICIAN STATED THAT HE BELIEVES THE EFFUSION WAS A RESULT OF A PERFORATION OF THE LEFT ATRIAL APPENDAGE BY THE CARDIOFOCUS LASER BALLOON CATHETER. DURING THIS PROCEDURE ONLY THE CARDIOFOCUS LASER BALLOON AND THE HD GRID ENTERED THE LEFT ATRIUM. 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
    1639888 HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE CARDIOFOCUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown