BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSSEPTAL NEEDLE

    MDR report key: 23644880 · Received November 25, 2025

    Report

    Report Number
    MW5179378
    Event Type
    Death
    Date Received
    November 25, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE FOR PVI, A PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPIRED. THE DIAGNOSTIC CATHETERS WERE PLACED IN THE HIS AND RIGHT ATRIUM CORONARY SINUS POSITION AND TRANSSEPTAL PUNCTURE WAS DONE SUCCESSFULLY. AFTERWARDS THE MAPPING CATHETER WAS PLACED IN THE LEFT ATRIUM AND STEERING WAS NOTED TO BE DIFFICULT. A CARDIAC ULTRASOUND SHOWED A PERICARDIAL EFFUSION IN THE PATIENT. A PERICARDIOCENTESIS WAS THEN PERFORMED. DURING THE NEXT HOUR APPROXIMATELY 1.5 LITERS BLOOD WERE WITHDRAWN FROM THE PERICARDIUM. THE EMERGENCY TEAM ENTERED THE ROOM AND SOON THE PATIENT SHOWED ASYSTOLE. THE EMERGENCY TEAM BEGAN WITH CPR, HOWEVER THE PATIENT DID NOT RECOVER AND EXPIRED IN THE CATH LAB. THE PHYSICIAN STATED THAT THERE WERE NO PRODUCT PERFORMANCE ISSUES WITH ANY ABBOTT PRODUCTS USED IN THIS CASE. ACCORDING TO THE PHYSICIAN THE CAUSE OF THE EFFUSION AND OF THE PATIENT'S DEATH ARE NOT CLEARLY KNOWN BUT THAT THE PERFORATION COULD HAVE POTENTIALLY OCCURRED AFTER TRANSSEPTAL PUNCTURE ON THE LEFT ATRIUM ROOF. "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
    2563576 TRANSSEPTAL NEEDLE TROCAR DRC MERIT MEDICAL SYSTEMS, INC. FND-019-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death