BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 17878306 · Received October 5, 2023

    Report

    Report Number
    2029046-2023-02238
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 6, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D4. PRIMARY UDI NUMBER (01)10846835000870(11)110119(21)11764 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

    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 18-OCT-2023, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH THE CARTO 3 SYSTEM, AND THE SYSTEM DISPLAYED A MAGNETIC SENSOR ERROR (ERROR CODE 6150) WHEN THE CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). THE CATHETER WAS NOT RECOGNIZED BY THE CARTO 3 SYSTEM. THE PROCEDURE CONTINUED WITHOUT RESOLUTION--BECAUSE HALFWAY THROUGH THE PROCEDURE THE ISSUE RESOLVED ON ITS OWN. DEVICE EVALUATION DETAILS: AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. IT WAS FOUND THAT THE REPORTED MAP SHIFT WAS CAUSED DUE TO HIGH METAL VALUES DURING MAPPING BELOW WARNING LEVEL. THE ISSUE IS RELATED TO SOFTWARE DEFECT. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #(B)(6), 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 THE CARTO 3 SYSTEM, AND THE SYSTEM DISPLAYED A MAGNETIC SENSOR ERROR (ERROR CODE 6150) WHEN THE CATHETER WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). THE CATHETER WAS NOT RECOGNIZED BY THE CARTO 3 SYSTEM. THE PROCEDURE CONTINUED WITHOUT RESOLUTION--BECAUSE HALFWAY THROUGH THE PROCEDURE THE ISSUE RESOLVED ON ITS OWN. HOWEVER, A MAP SHIFT OCCURRED AFTERWARD (AFTER THE MIDWAY POINT OF THE CASE). THE MAP SHIFT OCCURRED ABRUPTLY WHEN PERFORMING ABLATION IN THE LEFT VEINS AND ABOUT HALFWAY THROUGH THE PROCEDURE. THE DIFFERENCE IN DISTANCE FROM THE CATHETER'S ACTUAL LOCATION WAS ABOUT TWO CENTIMETERS. THE PATCHES WERE CHECKED AND DETERMINED TO BE OKAY. THERE WAS NO CHANGE IN RESPIRATION. THERE WAS NO PATIENT MOVEMENT. NO CARDIOVERSION HAD OCCURRED WHEN THE MAP SHIFT OCCURRED. THE SYSTEM GAVE NO ERROR, AND WAS DISCOVERED WHEN ABLATING ANTERIOR SIDE OF THE LEFT SUPERIOR VEIN. THE MAGNETIC SENSOR ERROR IS NOT MDR-REPORTABLE. THE MAP SHIFT IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245949 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SOUNDSTAR CATHETER