BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 21482580 · Received February 27, 2025

    Report

    Report Number
    2029046-2025-00596
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2-MAR-2025, BWI RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE MEDICAL TEAM DID IN FACT RECEIVED INTRACARDIAC (IC) SIGNAL WHEN THE CATHETER WAS CONNECTED TO THE PATIENT'S BODY. THE ONLY SIGNAL ISSUE IDENTIFIED OCCURRED WITH THE 2D RECORDING SYSTEM. AS A RESULT, THERE IS NO INFORMATION TO REPORT TO THE FDA. THIS EVENT IS NOT FDA-REPORTABLE. NO FURTHER REPORTS WILL BE SENT REGARDING THIS EVENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. 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 A CARDIAC ABLATION PROCEDURE WITH CARTO 3 SYSTEM AND THE MEDICAL TEAM WAS NOT ABLE TO GET MAPPING SIGNALS FROM THE IC (INTRACARDIAC) OUT CABLES. THE MEDICAL TEAM NOTED THAT THERE WAS NO AVAILABLE ECG (ELECTROCARDIOGRAM) SIGNAL TO MONITOR PATIENT HEART RHYTHM. THE SIGNAL LOSS WAS ALSO NOTED ON THE IC MAPPING CHANNEL AND ON THE 2D RECORDING SYSTEM. DURING THE SIGNAL LOSS ISSUE, THE CATHETER WAS NOT IN THE PATIENT'S BODY. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596238 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown