BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSPAN®

    MDR report key: 23645273 · Received November 25, 2025

    Report

    Report Number
    1721504-2025-00639
    Event Type
    Death
    Date Received
    November 25, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    DRC
    UDI-DI
    00884450489345
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE FOR PULMONARY VEIN ISOLATION (PVI), A PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPIRED. THE DIAGNOSTIC CATHETERS WERE PLACED IN THE BUNDLE OF 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 DURING THE NEXT HOUR APPROXIMATELY 1.5 LITERS BLOOD WERE WITHDRAWN FROM THE PERICARDIUM.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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563674 HEARTSPAN® TRANSSEPTAL NEEDLE KIT AND STYLET DRC MERIT MEDICAL SYSTEMS INC. 00884450489345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown