BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 18327670 · Received December 14, 2023

    Report

    Report Number
    2029046-2023-02959
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    October 1, 2023
    Report Date
    February 9, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K180238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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

    CORRECTION TO SECTION D4. PRIMARY UDI NUMBER (B)(4) AND TO SECTION G4. PMA/ 510(K) K180238. 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

    ON 21-JAN-2024, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THERE WAS NO ECG (ELECTROCARDIOGRAM) OR BS (BODY SURFACE) SIGNALS AVAILABLE. THE SIGNAL INTERFERENCE IMPACTED THE CARTO 3 SYSTEM. DURING THE ISSUE, THE AFFECTED CATHETER WAS NOT INSIDE OF THE PATIENT'S BODY. THE BS AND ECG CABLES WERE REPLACED FOR THE COMPLAINT. EVERYTHING WAS REPLACED FROM ECG CABLES TO ECG ELECTRODES AND EVEN THE LOCATION OF THE ELECTRODES ON THE BODY. NOTHING WAS WORKING WHILE CARTO WAS ON. WHEN THE MEDICAL TEAM TURNED OFF THE CARTO SYSTEM EVERYTHING ON THE RECORDING SYSTEM WAS WORKING. AFTER APPROXIMATELY TWO HOURS, THE SIGNALS WERE WORKING AGAIN. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE INVESTIGATION DETAILS: A FIELD SERVICE ENGINEER FOLLOWED UP WITH A COMPANY REPRESENTATIVE AND CONFIRMED THAT THE SIGNAL ISSUE WAS NOT DUPLICATED ON THE FOLLOWING CASES. THE DEVICE MANUFACTURER REQUESTED LOGS TO INVESTIGATE THE ISSUE BUT NO DATA WAS RECEIVED. THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED AND NO MORE SIMILAR PROBLEMS WERE FOUND SINCE THE ISSUE OCCURRED. THE SYSTEM IS READY FOR USE. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #3035637, 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 A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THERE WAS NO ECG (ELECTROCARDIOGRAM) OR BS (BODY SURFACE) SIGNALS AVAILABLE. THE SIGNAL INTERFERENCE IMPACTED THE CARTO 3 SYSTEM. DURING THE ISSUE, THE AFFECTED CATHETER WAS NOT INSIDE OF THE PATIENT'S BODY. THE BS AND ECG CABLES WERE REPLACED FOR THE COMPLAINT. EVERYTHING WAS REPLACED FROM ECG CABLES TO ECG ELECTRODES AND EVEN THE LOCATION OF THE ELECTRODES ON THE BODY. NOTHING WAS WORKING WHILE CARTO WAS ON. WHEN THE MEDICAL TEAM TURNED OFF THE CARTO SYSTEM EVERYTHING ON THE RECORDING SYSTEM WAS WORKING. AFTER APPROXIMATELY TWO HOURS, THE SIGNALS WERE WORKING AGAIN. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261357 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown