BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3

    MDR report key: 23409026 · Received October 28, 2025

    Report

    Report Number
    2029046-2025-03604
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 18, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K231207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 28-OCT-2025, NOTED A CORRECTION TO THE 3500A INITIAL UNDER G4. PMA/ 510(K) FIELD AS LEFT BLANK. SHOULD HAVE PROCESSED AS K231207. THE INVESTIGATION WAS COMPLETED ON 18-NOV-2025. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. DURING THE PROCEDURE, WHILE USING A JET VENTILATOR, A MAP SHIFT OCCURRED ON THE CARTO 3 SYSTEM MAP. NO PATIENT MOVEMENT, NO ERRORS DISPLAYED, AND THEY WERE NOT RESPIRATORY GATED. THERE WAS NO A TEMPLATE IN USE. ALTHOUGH THERE WERE NO ERRORS PRESENT, IT WAS VERY OBVIOUS THAT THERE WAS A 1-2 MM DIFFERENCE IN MAP. THEY ALSO USED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TO CONTINUE AND COMPLETE THE PROCEDURE. THE CARTO 3 MANUFACTURER INVESTIGATED THE ISSUE BASED ON THE STUDY DIGITAL DATA. IT WAS FOUND THAT THE LOCATION OF THE HEART WAS CHANGED DUE TO THE BREATHING AMPLITUDE CHANGE. CARTO DOES NOT COMPENSATE FOR THAT AS THE COMPENSATION IS FOR BODY MOVEMENT AS REFLECTED VIA BACK PATCH LOCATION MOVEMENT. THE SYSTEM BEHAVIOR WAS CORRECT. THE SYSTEM BEHAVED AS EXPECTED. ACCORDING TO CARTO 3 INSTRUCTIONS FOR USE: "WHEN THE RELATIVE POSITION BETWEEN THE PATCHES REMAINS THE SAME BUT THE POSITION OF THE HEART RELATIVE TO THE BACK PATCHES HAS CHANGED (FOR EXAMPLE, AFTER REPOSITIONING THE PATIENT'S HEAD ON A PILLOW OR MOVING THE PATIENT'S ARM WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS, OR AFTER THE PATIENT IS CARDIOVERTED), THE SYSTEM WILL NOT GIVE A WARNING AND AN INCORRECT MAP (MAP SHIFT) MIGHT BE GENERATED". THE SYSTEM IS READY FOR USE. THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE SYSTEM #34704, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND THE REPORTED MAP SHIFT WITH NO ERROR MESSAGE, NO PATIENT MOVEMENT AND NO CARDIOVERSION PRIOR TO THE MAP SHIFT OCCURRED. DURING AN ATRIAL FIBRILLATION PROCEDURE, WHILE USING A JET VENTILATOR, A MAP SHIFT OCCURRED ON THE CARTO 3 SYSTEM MAP. NO PATIENT MOVEMENT, NO ERRORS DISPLAYED, AND THEY WERE NOT RESPIRATORY GATED. THERE WAS NO A TEMPLATE IN USE. ALTHOUGH THERE WERE NO ERRORS PRESENT, IT WAS VERY OBVIOUS THAT THERE WAS A 1-2 MM DIFFERENCE IN MAP. THEY ALSO USED ICE TO CONTINUE AND COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 03-OCT-2025. THE ISSUE WAS SEEN DURING ABLATION. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT. THE PATIENT DID NOT COUGH BEFORE DETECTING THE SHIFT. THE CRNA STATED THERE WERE NO CHANGES IN THE PATIENT¿S BREATHING NOR VENTILATION BEFORE THE MAP SHIFT. THE PATIENT¿S ARM WAS NOT MOVED WITHOUT CHANGING THE PATIENT¿S POSITION ON THE MATTRESS. THE REPORTED MAP SHIFT ISSUE WITH NO ERROR MESSAGE AND NO PATIENT MOVEMENT IS ASSESSED AS NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 03-OCT-2025 THAT THE THEY DID NOT PERFORM A CARDIOVERSION PRIOR TO THE MAP SHIFT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 03-OCT-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254587 CARTO 3 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN SYSTEM.| UNK JET VENTILATOR.| UNK_OCTARAY NAV.| UNK_QDOT MICRO.