BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERIT MEDICAL PERICARDIOCENTESIS KIT - 8.3 F (2.77 MM) HIGH FLOW PIGTAIL CATHETE

    MDR report key: 21491533 · Received February 28, 2025

    Report

    Report Number
    MW5167050
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    February 23, 2025
    Report Date
    February 25, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS
    Product Code
    PXU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN THE CATH LAB WHILE PERFORMING THE PERICARDIAL FLUID DRAINAGE PATIENT INITIALLY BECAME HEMODYNAMICALLY UNSTABLE AND THEN CODE BLUE WAS CALLED. CODE BLUE WAS TERMINATED AS PER FAMILY REQUEST AND PATIENT PASSED. POST-PROCEDURE, GUIDEWIRE FROM PERICARDIOCENTESIS KIT WAS FOUND TO BE SHEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665579 MERIT MEDICAL PERICARDIOCENTESIS KIT - 8.3 F (2.77 MM) HIGH FLOW PIGTAIL CATHETE FLUID DRAINAGE TRAY PXU MERIT MEDICAL SYSTEMS T2933767

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death