BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABLACATH CATHETER (OPTIMAP CATHETER)

    MDR report key: 20516255 · Received October 23, 2024

    Report

    Report Number
    3013627970-2024-00001
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    November 27, 2023
    Report Date
    October 22, 2024
    Manufacturer
    CORTEX INC
    Product Code
    MTD
    UDI-DI
    00860457001544
    PMA / PMN Number
    K223666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATING PHYSICIAN INITIALLY NOTED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. THE EVENT WAS LATER ADJUDICATED BY THE CEC ((B)(6) 2024) AS POSSIBLY RELATED TO THE DEVICE AND STANDARD OF CARE PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT HAD ATRIAL FIBRILLATION ABLATION PERFORMED ON (B)(6) 2023. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2023 DUE TO MILD CHEST PAIN AND DIFFICULTY BREATHING FOR 2 DAYS. AN ECHOCARDIOGRAM SHOWED A LARGE PERICARDIAL EFFUSION W/TAMPONADE AND PATIENT WAS ADMITTED SAME DAY. PERICARDIOCENTESIS WAS PERFORMED THE NEXT DAY. 610ML FLUID WAS DRAINED. A REPEAT ECHOCARDIOGRAM ON (B)(6) 2023 SHOWED MINIMAL PERICARDIAL EFFUSION. THE PATIENT DECREASED COLCHICINE, ADDED PREDNISONE, CONTINUED ELIQUIS AND PROPAFENONE. INCREASE METOPROLOL TO BID FOR RATE CONTROL. PATIENT WAS DISCHARGED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352902 ABLACATH CATHETER (OPTIMAP CATHETER) CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD CORTEX INC AB-0003-50 Q8513870 00860457001544

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R