BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 18230590 · Received November 29, 2023

    Report

    Report Number
    2029046-2023-02773
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 1, 2023
    Report Date
    January 11, 2024
    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

    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. MANUFACTURER'S REFERENCE NUMBER: (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 PRODUCT INVESTIGATION WAS COMPLETED ON 17-DEC-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED MID-PROCEDURE. THE ISSUE WAS NOTICED WHEN THE FORCE READINGS OF THE CATHETER ¿APPEARED OFF¿. THE LOCATION OF THE CATHETER WAS DISPLAYED ON THE CARTO 3 SYSTEM AS POKING OUT OF THE FAST ANATOMICAL MAPPING (FAM), EVEN THOUGH THE FORCE DISPLAYED ON THE CARTO 3 SYSTEM WAS ZERO. THE DOCTOR WAS HAVING A HARD TIME FIGURING OUT WHERE THE CATHETER WAS BECAUSE THE IMAGE DID NOT ALIGN WITH WHERE THE CATHETER WAS IN THE HEART. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS ABOUT 5-6MM. NO CARDIOVERSION OR PATIENT MOVEMENT WAS DETECTED BEFORE THE MAP SHIFT. THERE WERE NO ERRORS DISPLAYED ON THE CARTO 3 SYSTEM AND THAT NO CARDIOVERSION WAS DONE. THE FLUORO WAS NOT BEING USED. THEY REMAPPED AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: IT WAS CONFIRMED THAT THE ISSUE WAS NOT DUPLICATED IN THE FOLLOWING CASE AFTER USING DEFAULT TEMPLATE. AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. IT WAS FOUND THAT THE REPORTED ISSUE WAS RELATED TO PATIENT MOVEMENT. 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. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE CARTO SYSTEM # (B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONALLY, THE MANUFACTURED DATE HAS BEEN PROVIDED. THEREFORE, FIELD H4. DEVICE MANUFACTURE DATE HAS BEEN POPULATED. 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 A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED MID-PROCEDURE. THE ISSUE WAS NOTICED WHEN THE FORCE READINGS OF THE CATHETER ¿APPEARED OFF¿. THE LOCATION OF THE CATHETER WAS DISPLAYED ON THE CARTO 3 SYSTEM AS POKING OUT OF THE FAST ANATOMICAL MAPPING (FAM), EVEN THOUGH THE FORCE DISPLAYED ON THE CARTO 3 SYSTEM WAS ZERO. THE DOCTOR WAS HAVING A HARD TIME FIGURING OUT WHERE THE CATHETER WAS BECAUSE THE IMAGE DID NOT ALIGN WITH WHERE THE CATHETER WAS IN THE HEART. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS ABOUT 5-6MM. NO CARDIOVERSION OR PATIENT MOVEMENT WAS DETECTED BEFORE THE MAP SHIFT. THERE WERE NO ERRORS DISPLAYED ON THE CARTO 3 SYSTEM AND THAT NO CARDIOVERSION WAS DONE. THE FLUORO WAS NOT BEING USED. THEY REMAPPED AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888179 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown