BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 17985039 · Received October 23, 2023

    Report

    Report Number
    2029046-2023-02396
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 27, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. IT WAS REPORTED BY THE CALLER THAT THE CARTO® 3 SYSTEM DISPLAYED A MAP SHIFT. THE CALLER NOTED THAT DURING THE PROCEDURE, DURING ABLATION, THE ANATOMICAL MAP SEEMED TO HAVE SHIFTED. THE CALLER NOTED THAT ALL METAL VALUES WERE ADEQUATE, NO CARDIOVERSION HAD BEEN PERFORMED, AND NO ERROR MESSAGES WERE DISPLAYED ON THE CARTO® 3 SYSTEM. TO CONTINUE WITH THE CASE, THE BWI REPRESENTATIVE REMAPPED THE CHAMBER OF INTEREST. AFTER THE REMAP, THE CALLER NOTED A SIGNIFICANT DIFFERENCE BETWEEN THE ORIGINAL MAP AND THE REMAP. THE CALLER NOTED THAT THE MAPPED SEEMED TO HAVE SHIFTED "ABOUT AN INCH" POSTERIOR AND SUPERIOR. DEVICE EVALUATION DETAILS: THE BIOSENSE WEBSTER INC (BWI) FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE BWI REPRESENTATIVE WHO INDICATED THE MAP SHIFT OCCURRED TO DUE TO PATIENTS LARGE SIZE (163KG). THE ISSUE NOT DUPLICATED DURING NEXT CASE. SYSTEM IS READY FOR USE. IN ADDITION, THE ISSUE WAS INVESTIGATED BY THE DEVICE MANUFACTURER. THE ISSUE WAS NOT REPRODUCED IN THE LAB. NO ADDITIONAL INVESTIGATION CAN BE PERFORMED AS THE DATA RELATED TO THE ISSUE WAS NOT PROVIDED. IN ADDITION, THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH THIS SPECIFIC SYSTEM WAS REVIEWED AND IT WAS FOUND THAT THE ISSUE WAS NOT REPORTED ANYMORE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM # (B)(6) WAS REVIEWED. THERE WERE NO ADDITIONAL COMPLAINTS THAT ARE SIMILAR TO THIS REPORTED ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE SYSTEM (B)(6), AND NO INTERNAL ACTION 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 REF. # (B)(4).

    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

    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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. IT WAS REPORTED BY THE CALLER THAT THE CARTO® 3 SYSTEM DISPLAYED A MAP SHIFT. THE CALLER NOTED THAT DURING THE PROCEDURE, DURING ABLATION, THE ANATOMICAL MAP SEEMED TO HAVE SHIFTED. THE CALLER NOTED THAT ALL METAL VALUES WERE ADEQUATE, NO CARDIOVERSION HAD BEEN PERFORMED, AND NO ERROR MESSAGES WERE DISPLAYED ON THE CARTO® 3 SYSTEM. TO CONTINUE WITH THE CASE, THE BWI REPRESENTATIVE REMAPPED THE CHAMBER OF INTEREST. AFTER THE REMAP, THE CALLER NOTED A SIGNIFICANT DIFFERENCE BETWEEN THE ORIGINAL MAP AND THE REMAP. THE CALLER NOTED THAT THE MAPPED SEEMED TO HAVE SHIFTED "ABOUT AN INCH" POSTERIOR AND SUPERIOR. NO ERROR CODES DISPLAYED. MAP SHIFT WAS DETECTED BY PHYSICIAN AS ANATOMICAL SHELL DID NOT SEEM ACCURATE. NEW MAP WAS CREATED AND OBVIOUS DISCREPANCY NOTED BETWEEN INITIAL LEFT ATRIAL MAP AND NEW LEFT ATRIAL MAP. ORIGINAL MAP IS GLASS MODE, NEW MAP IS GREY SHELL. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT AND THERE WAS NO PATIENT MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227675 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown