BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 18085593 · Received November 7, 2023

    Report

    Report Number
    2029046-2023-02558
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 12, 2023
    Report Date
    June 24, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D4. PRIMARY UDI NUMBER (B)(4) AND TO SECTION G4. PMA/ 510(K) K213264. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    PER INTERNAL REVIEW ON 18-JUN-2024, IT WAS IDENTIFIED THAT THE G3 DATE RECEIVED BY MANUFACTURER DATE ON THE INITIAL REPORT WAS MISTAKENLY INDICATED AS 12-OCT-2023. THE ACTUAL DATE IS 23-OCT-2023, WHICH WAS WHEN IT WAS CONFIRMED THAT THERE WAS NO ERROR MESSAGE IDENTIFIED IN THE CARTO SYSTEM. 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

    PER INTERNAL REVIEW ON 24-JUN-2024, IT WAS IDENTIFIED THAT THE PREVIOUSLY SUBMITTED CORRECTION SUPPLEMENTAL STATED THAT ON 23-OCT-2023, "IT WAS CONFIRMED THAT THERE WAS NO ERROR MESSAGE IDENTIFIED IN THE CARTO SYSTEM." THAT INFORMATION IS INACCURATE. THE CORRECT STATEMENT IS AS FOLLOWS: "ON 23-OCT-2023, IT WAS CONFIRMED THE PHYSICIAN DIDN¿T HAVE ANY INTACT ECG SIGNALS TO MONITOR THE PATIENT." 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. 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. 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

    ON 15-FEB-2024, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THE MEDICAL TEAM NOTED ECG (ELECTROCARDIOGRAM) NOISE FROM CARTO AND EP RECORDING WHEN PACING AND ABLATING. THE PROCEDURE WAS COMPLETED WITH THE NOISE. NO PATIENT CONSEQUENCES WERE NOTED. THE NOISE OCCURRED ON BODY SURFACE (BS) AND ECG (ELECTROCARDIOGRAM) DURING ABLATION. WHEN PACING FROM 20A 1-2 ONLY THE BS ECG SATURATES ON CARTO AND EP RECORDING SYSTEM, RESULTING IN SIGNAL LOSS FOR BOTH. DEVICE EVALUATION DETAILS: IT WAS CONFIRMED THAT THE ISSUE WAS RESOLVED BY REPLACING THE ECG (ELECTROCARDIOGRAM) CARD WITH ANOTHER ONE THAT WAS DELIVERED TO THE CUSTOMER. THE SYSTEM IS READY FOR USE. THE SUSPECTED ECG CARD WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. THE CARD WAS TESTED BUT THE REPORTED ISSUE WAS NOT DUPLICATED. IN ADDITION A CORROSION MARK WERE FOUND ON THE CARD. THE CORROSION IS NOT RELATED TO THE REPORTED ISSUE. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #29227, 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THE MEDICAL TEAM NOTED ECG NOISE FROM CARTO AND EP RECORDING WHEN PACING AND ABLATING. THE PROCEDURE WAS COMPLETED WITH THE NOISE. NO PATIENT CONSEQUENCES WERE NOTED. THE NOISE OCCURRED ON BODY SURFACE (BS) AND ECG (ELECTROCARDIOGRAM) DURING ABLATION. WHEN PACING FROM 20A 1-2 ONLY THE BS ECG SATURATES ON CARTO AND EP RECORDING SYSTEM, RESULTING IN SIGNAL LOSS FOR BOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340886 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown