BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 16384268 · Received February 16, 2023

    Report

    Report Number
    2029046-2023-00310
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 18, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO FG540000, APPROVED UNDER 510K/PMA # K042999. INITIAL REPORTER PHONE : (B)(6). THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    THE HARDWARE INVESTIGATION WAS COMPLETED ON 03-MAY-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. IT WAS REPORTED THAT AFTER LEFT PULMONARY VEIN ISOLATION (LPVI), DURING RIGHT PULMONARY VEIN ISOLATION (RPVI), THERE WAS A STRANGE FEELING FELT IN THE MAP, AND WHEN MAPPING WAS PERFORMED, GREATLY SHIFTED UP AND DOWN. THE PROCEDURE ITSELF WAS COMPLETED UNEVENTFULLY. WILL BE VERIFIED AT THE SITE IN THE FUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT A MAP SHIFT OCCURRED. THE ISSUE WAS SEEN DURING MAPPING OR ABLATING. THE ISSUE WAS RESOLVED BY MEASURING SID TEST AGAIN. NO MAP SHIFT HAS OCCURRED SINCE THE SID TEST WAS RE-MEASURED AND PROCEDURE WAS PERFORMED BY THE APPROPRIATE VALUE. HARDWARE INVESTIGATION DETAILS: IT WAS CONFIRMED THAT THE ISSUE WAS RESOLVED BY MEASURING SID TEST AGAIN. IN ADDITION, AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. THE LOGS WERE REQUESTED IN ORDER TO INVESTIGATE THE ISSUE; HOWEVER, THE BIOSENSE WEBSTER INC. (BWI) FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE DATA WAS NO LONGER AVAILABLE. THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED, AND NO SIMILAR PROBLEMS WERE FOUND SINCE THE ISSUE OCCURRED. THE SYSTEM IS READY FOR USE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM# (B)(6) WAS REVIEWED. NO SIMILAR COMPLAINTS WERE FOUND. 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 A CARDIAC ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. IT WAS REPORTED THAT AFTER LEFT PULMONARY VEIN ISOLATION (LPVI), DURING RIGHT PULMONARY VEIN ISOLATION (RPVI), THERE WAS A STRANGE FEELING FELT IN THE MAP, AND WHEN MAPPING WAS PERFORMED, GREATLY SHIFTED UP AND DOWN. THE PROCEDURE ITSELF WAS COMPLETED UNEVENTFULLY. WILL BE VERIFIED AT THE SITE IN THE FUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT A MAP SHIFT OCCURRED. THE ISSUE WAS SEEN DURING MAPPING OR ABLATING. THE ISSUE WAS RESOLVED BY MEASURING SID TEST AGAIN. NO MAP SHIFT HAS OCCURRED SINCE THE SID TEST WAS RE-MEASURED AND PROCEDURE WAS PERFORMED BY THE APPROPRIATE VALUE. THE MAP SHIFT ISSUE WAS ASSESSED AS A US FDA REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680291 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown