BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERICARDIOCENTESIS KIT.8.3F (2.77 MM).40 CM (15.7").PIGTAIL.

    MDR report key: 21584749 · Received March 12, 2025

    Report

    Report Number
    1125782-2025-00002
    Event Type
    Death
    Date Received
    March 12, 2025
    Date of Event
    February 23, 2025
    Report Date
    March 12, 2025
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    PXU
    UDI-DI
    00884450727911
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    MEDWATCH RECEIVED MW5167050 - THE ACCOUNT ALLEGES THAT IN THE CATH LAB WHILE PERFORMING A PERICARDIAL FLUID DRAINAGE PROCEDURE, THE PATIENT INITIALLY BECAME HEMODYNAMICALLY UNSTABLE AND A CODE BLUE WAS CALLED. THE CODE BLUE WAS TERMINATED PER THE FAMILIES REQUEST AND THE PATIENT EXPIRED. A GUIDEWIRE FROM PERICARDIOCENTESIS KIT WAS FOUND DAMAGED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399565 PERICARDIOCENTESIS KIT.8.3F (2.77 MM).40 CM (15.7").PIGTAIL. FLUID DRAINAGE TRAY PXU MERIT MEDICAL SYSTEMS INC. T2933767 00884450727911

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death| R