BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 17878692 · Received October 5, 2023

    Report

    Report Number
    2029046-2023-02240
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 8, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 8-SEP-2023. THE ACTUAL DATE IS 12-SEP-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

    E1 INITIAL REPORTER EMAIL: (B)(6). 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 24-OCT-2023, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN FOCAL ATRIAL TACHYCARDIA RIGHT (FOCAL AT RIGHT) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND A MAP SHIFT OCCURRED--THE ANATOMY WAS SHIFTED WITH THE POSITION OF THE CATHETER BUT THEY ARE SURE THEY DIDN¿T HAVE ANY. THE MEDICAL TEAM CHOSE TO CONTINUE THE PROCEDURE WITH THE MAP IN THAT SHIFTED STATE DUE TO THE PHYSICIAN'S LEVEL OF EXPERIENCE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES OR SURGICAL DELAY. DEVICE EVALUATION DETAILS: THE FIELD SERVICE ENGINEER CONFIRMED THAT THE SOFTWARE WAS REIMAGED. ACCEPTANCE TESTING PROCEDURE (ATP). THE SYSTEM WAS OPERATIONAL. SERVICE WAS COMPLETED. THE ISSUE WAS INVESTIGATED BY THE DEVICE MANUFACTURER. IT WAS FOUND THAT MAP SHIFT CAUSED BY MAPPING WITH DIFFERENT METAL VALUES BELOW WARNING LEVEL. THE ISSUE IS RELATED TO AN IDENTIFIED DEFECT. INTERNAL CORRECTIVE ACTIONS HAVE BEEN OPENED FOR THE MAP SHIFT AND SOFTWARE ISSUES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE 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 FOCAL ATRIAL TACHYCARDIA RIGHT (FOCAL AT RIGHT) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND A MAP SHIFT OCCURRED--THE ANATOMY WAS SHIFTED WITH THE POSITION OF THE CATHETER BUT THEY ARE SURE THEY DIDN¿T HAVE ANY. THE MEDICAL TEAM CHOSE TO CONTINUE THE PROCEDURE WITH THE MAP IN THAT SHIFTED STATE DUE TO THE PHYSICIAN'S LEVEL OF EXPERIENCE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES OR SURGICAL DELAY. THE MAP SHIFT IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009987 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PENTARAY CATHETER.| THERMOCOOL SMARTTOUCH.