BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 16812583 · Received April 25, 2023

    Report

    Report Number
    2029046-2023-00891
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    February 22, 2023
    Report Date
    August 8, 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

    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 THE MAP OF THE FAST ANATOMICAL MAPPING (FAM) IS DISPLACED AROUND THE PULMONARY VEIN ISOLATION (PVI) (VERSION INFORMATION: V 7.2.40.250). THERE WAS NO ERROR. THERE WAS A GAP FELT 10 MINUTES AFTER THE START OF ABLATION. WHEN A FAM MAP WAS CREATED UNDER THE SAME SITUATION, THERE WAS A MAP SHIFT. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS 2¿4MM. THERE WAS NO DEFIBRILLATION AND THERE WAS NO PATIENT MOVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. HARDWARE EVALUATION DETAILS: AN INVESTIGATION WAS INITIATED BY THE DEVICE MANUFACTURER TO INVESTIGATE THE ISSUE. DATA RELATED TO THE REPORTED ISSUE WAS REQUESTED FROM THE ACCOUNT; HOWEVER, THE DATA RELATED TO THE ISSUE IS NO LONGER AVAILABLE AS IT WAS DELETED FROM THE WORKSTATION (WS). NO INVESTIGATION CAN BE PERFORMED AS THE DATA RELATED TO THE ISSUE WAS NOT PROVIDED. 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 ADDITIONAL COMPLAINT WAS 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).

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE: (B)(6). 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 CARTO® 3 SYSTEM APPROVED UNDER 510K # K042999. 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).

    Description of Event or Problem · 0

    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 THE MAP OF THE FAST ANATOMICAL MAPPING (FAM) IS DISPLACED AROUND THE PULMONARY VEIN ISOLATION (PVI) (VERSION INFORMATION: V 7.2.40.250). THERE WAS NO ERROR. THERE WAS A GAP FELT 10 MINUTES AFTER THE START OF ABLATION. WHEN A FAM MAP WAS CREATED UNDER THE SAME SITUATION, THERE WAS A MAP SHIFT. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS 24MM. THERE WAS NO DEFIBRILLATION AND THERE WAS NO PATIENT MOVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668603 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown