BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSESELECT¿

    MDR report key: 22912104 · Received August 28, 2025

    Report

    Report Number
    MW5175299
    Event Type
    Death
    Date Received
    August 28, 2025
    Date of Event
    April 17, 2025
    Report Date
    August 29, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE S70 ULTRASOUND MACHINE DISPLAYED AN ERROR - "SET UP PROBLEM OCCURRED. PLEASE RESELECT PROBE TO CONTINUE" (ERROR CODE UNKNOWN). THE PATIENT INTERFACE UNIT (PIU) WAS REBOOTED WITHOUT RESOLUTION. THEY RESEATED THE CATHETER AND THE PROBE AT THE SAME TIME WITHOUT RESOLUTION. THEY REPLACED THE CATHETER AND THE PROBE AT THE SAME TIME AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. IT WAS ALSO REPORTED THAT WHILE ABLATING IN THE LEFT ATRIAL APPENDAGE, THE PHYSICIAN WAS LOOKING AT THE ARTERIAL LINE AND CONFIRMED THERE WAS A SUDDEN DROP IN BLOOD PRESSURE ON THE PATIENT. THE PHYSICIAN CHECKED FOR A PERICARDIAL EFFUSION, BUT A PERICARDIAL EFFUSION WAS NOT PRESENT. THE PHYSICIAN DECIDED TO PERFORM CARDIOPULMONARY RESUSCITATION (CPR) ON THE PATIENT UNTIL THE RESPONSE TEAM ARRIVED. WHEN THE RESPONSE TEAM ARRIVED, THE ELECTRICAL ACTIVITY WAS STILL ACTIVE IN THE HEART AND WAS CONFIRMED BY THE CORONARY SINUS (CS) CATHETER STILL IN THE BODY, BUT THERE WAS NO PULSE. WHILE THE CS CATHETER WAS STILL IN THE BODY, AND THE PATIENT'S CONDITION REMAINED THE SAME WITH LOW BLOOD PRESSURE, ACTIVE ELECTRICAL ACTIVITY IN THE HEART, AND NO PULSE, THE RESPONSE TEAM CONTINUED WITH THE CPR. ANOTHER PHYSICIAN CONFIRMED A SMALL PERICARDIAL EFFUSION IN THE VENTRICULAR WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A PERICARDIOCENTESIS WAS PERFORMED AND THE CPR CONTINUED. AT ONE POINT IN TIME, THE ELECTRICAL ACTIVITY IN THE HEART WAS LOST WHILE THE CS CATHETER WAS STILL IN THE BODY. THE PATIENT WAS DEFIBRILLATED, BUT THERE WAS NO CHANGE IN THE PATIENT SITUATION, AND THE CPR WAS CONTINUED. AT THIS POINT, THE REPORTER STEPPED OUT OF THE ROOM. WHEN THE REPORTER CAME BACK IN THE ROOM, THE PATIENT WAS ANNOUNCED TO BE DECEASED. (B)(6) PULSESELECT¿ PULSED FIELD ABLATION (PFA) SYSTEM WAS IN USE. THE FOLLOWING BWI PRODUCTS WERE IN USE: CS CATHETER (LOT# UNKNOWN; CAT # UNKNOWN); 2 NUVISION ULTRASOUND CATHETER - (LOT - 31424477L; REF - FG10593) (31424483L - FG10593). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 8/29/2025 FOR MW5175299 TO UPDATE BRAND NAME AND MANUFACTURER. 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
    2163021 PULSESELECT¿ PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death