BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 22680661 · Received July 31, 2025

    Report

    Report Number
    3008452825-2025-00386
    Event Type
    Injury
    Date Received
    July 31, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ABBOTT MEDICAL, COSTA RICA LTDA
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THE PRODUCT'S MODEL/LOT NUMBER WAS UNABLE TO BE OBTAINED AND THEREFORE FULL UDI INFORMATION(D4) AND 510K(G3) CANNOT BE NOT PROVIDED 2032227-2025-223430

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE. A LARGE BUT STABLE PRE-EXISTING EFFUSION WAS OBSERVED BEFORE THE PROCEDURE BEGAN. AFTER TRANSSEPTAL PUNCTURE (TSP) WITH A NON-(B)(6) DEVICE AND ADMINISTRATION OF HEPARIN, A ROUTINE MIDPROCEDURE CHECK REVEALED THAT THE EFFUSION HAD INCREASED. THE PHYSICIAN ABORTED THE PROCEDURE, REVERSED THE HEPARIN, AND PLACED THE PATIENT UNDER OBSERVATION. THERE WERE NO SIGNS OF CARDIAC TAMPONADE, NO DROP IN BLOOD PRESSURE, AND NO INTERVENTION WAS REQUIRED. A CT ANGIOGRAPHY WAS PERFORMED TO RULE OUT AORTIC DISSECTION, WHICH WAS CONSIDERED UNRELATED TO THE PROCEDURE AND POTENTIALLY LINKED TO THE PATIENT'S PRIOR VALVE SURGERIES. NO FURTHER COMPLICATIONS WERE REPORTED. 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
    213661 TRANSSEPTAL NEEDLE, BRK SERIES TROCAR DRC ABBOTT MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other