BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 18378726 · Received December 21, 2023

    Report

    Report Number
    2029046-2023-03059
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 24, 2023
    Report Date
    March 14, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER INTERNAL REVIEW ON (B)(6) 2024, THE PRODUCT INVESTIGATION WAS UPDATED WITH FURTHER DETAILS. AS PREVIOUS STATED, THE MAP SHIFT WAS RELATED TO PATIENT MOVEMENT. ACCORDING TO CARTO 3 INSTRUCTIONS FOR USE, (P.N. UG-5400-0072H, REV. 02 ): "WHEN THE RELATIVE POSITION BETWEEN THE PATCHES REMAINS THE SAME BUT THE POSITION OF THE HEART RELATIVE TO THE BACK PATCHES HAS CHANGED (FOR EXAMPLE, AFTER REPOSITIONING THE PATIENT'S HEAD ON A PILLOW OR MOVING THE PATIENT'S ARM WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS, OR AFTER THE PATIENT IS CARDIOVERTED), THE SYSTEM WILL NOT GIVE A WARNING AND AN INCORRECT MAP (MAP SHIFT) MIGHT BE GENERATED.". ISSUE IS RELATED TO USER ERROR. 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

    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

    ON (B)(6) 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THE MAP SHIFTED WITHOUT ANY ERROR DID DISPLAYED ON CARTO. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT. THE PATIENT DID NOT MOVE AS WELL. THE MEDICAL TEAM REBOOTED THE SYSTEM AND LAUNCHED A NEW MAP AND ISSUE HAS BEEN SOLVED. AS A RESULT OF THE MAP SHIFT, THE PHYSICIAN HAD TO ABLATE AT A LOCATION THAT THEY HAD NOT ORIGINALLY PLANNED TO. THE PROCEDURE WAS DELAYED FOR 5 MINUTES. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE MANUFACTURER INVESTIGATED THE ISSUE. IT WAS FOUND THAT THE REPORTED ISSUE WAS RELATED TO PATIENT MOVEMENT. THE SYSTEM IS READY FOR USE. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 # 10320, 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

    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).

    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 THE MAP SHIFTED WITHOUT ANY ERROR DID DISPLAYED ON CARTO. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT. THE PATIENT DID NOT MOVE AS WELL. THE MEDICAL TEAM REBOOTED THE SYSTEM AND LAUNCHED A NEW MAP AND ISSUE HAS BEEN SOLVED. AS A RESULT OF THE MAP SHIFT, THE PHYSICIAN HAD TO ABLATE AT A LOCATION THAT THEY HAD NOT ORIGINALLY PLANNED TO. THE PROCEDURE WAS DELAYED FOR 5 MINUTES. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305118 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown