BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK-1 XS SERIES

    MDR report key: 24163956 · Received January 23, 2026

    Report

    Report Number
    3008452825-2026-00032
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    January 1, 2025
    Report Date
    January 23, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE. MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF INTERVENTIONAL CARDIOLOGY 2025.1 JOHN WILEY AND SONS INC. (2025). "ACUTE AND SHORT-TERM HEMODYNAMIC AND ECHOCARDIOGRAPHY CHANGES DURING AND AFTER LEFT ATRIAL APPENDAGE CLOSURE"; DALIBOR HERMAN TWO CENTERS ENROLLED PATIENTS FOR LAAC FROM JANUARY 2022 TO JULY 2024. INVASIVE HEMODYNAMIC MEASUREMENTS OF LEFT ATRIAL PRESSURE (LAP) WERE TAKEN AFTER THE TRANSSEPTAL PUNCTURE AND POST DEVICE DEPLOYMENT (BOTH BEFORE AND AFTER ISOMETRIC EXERCISE). THE HEART FAILURE (HF) BIOMARKERS (NT-PROBNP, NT-PRO ANP, AND GDF-15) WERE ASSESSED BEFORE AND 3 MONTHS AFTER LAAC. THE ECHOCARDIOGRAPHIC PARAMETERS WERE ASSESSED BEFORE AND 6 MONTHS AFTER LAAC. ADVERSE EVENTS OF 2 PERICARDIAL EFFUSIONS WHICH REQUIRED A PERICARDIOCENTESIS AND 1 TIA WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221751 TRANSSEPTAL NEEDLE, BRK-1 XS SERIES Trocar DRC ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L