BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 15009125 · Received July 13, 2022

    Report

    Report Number
    2029046-2022-01601
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 20, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 4. 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: PC-001146227.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) DURING AN INTERNAL REVIEW IT WAS NOTED THAT THE H6. INVESTIGATION CONCLUSION WAS MISSING FROM THE 3500A FOLLOW-UP 3500A FOLLOW-UP #1. THEREFORE, PROCESSED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED ON 07-SEP-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM. DURING THE PROCEDURE THERE WAS A DRASTIC MAP SHIFT ON THE CARTO® 3 SYSTEM. THEY HAD TO CREATE ALL NEW FAST ANATOMICAL MAPPING (FAM) DUE TO THE EXTREME SHIFT IN THE MAP. THE PATIENT HAD COME INTO THE LAB IN SINUS RHYTHM AND NO CARDIOVERSION HAD BEEN DONE. THERE WERE NO ERRORS PRESENT FOR THE MAJORITY OF THE PROCEDURE. ERROR 257: BACK PATCH DETACH APPEARED TOWARDS THE END OF THE PROCEDURE. THE METAL VALUES WERE ALL WITHIN NORMAL RANGE. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE DOES NOT KNOW WHAT CAUSED THE MAP SHIFT. ADDITIONAL INFORMATION WAS RECEIVED. NO ERROR MESSAGE AS THE MAP SHIFT WAS DISCOVERED WHILE TRYING TO ABLATE AND WAS INSIDE A VEIN AND CLEARLY DID NOT MATCH CAM DATA. THE ISSUE WAS SEEN DURING ABLATING AND THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER THE MAP SHIFT WAS GREATER THAN 3MM. THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. AN INVESTIGATION WAS INITIATED BY DEVICE MANUFACTURER TO INVESTIGATE THE ISSUE. IT WAS FOUND THAT THE REPORTED MAP SHIFT WAS CAUSED DUE TO PATIENT MOVEMENT. ACCORDING TO CARTO 3 INSTRUCTIONS FOR USE: "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." THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED AND NO MORE SIMILAR PROBLEMS WERE FOUND SINCE THE ISSUE OCCURRED. THE SYSTEM IS READY FOR USE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE SYSTEM, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. H6. COMPONENT CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE¿ REPRESENTS UE-MAP SHIFT. 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 PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND THERE WAS A MAP SHIFT WITH NO ERROR MESSAGE, NO PATIENT MOVEMENT AND NO CARDIOVERSION PERFORMED. DURING THE PROCEDURE THERE WAS A DRASTIC MAP SHIFT ON THE CARTO® 3 SYSTEM. THEY HAD TO CREATE ALL NEW FAST ANATOMICAL MAPPING (FAM) DUE TO THE EXTREME SHIFT IN THE MAP. THE PATIENT HAD COME INTO THE LAB IN SINUS RHYTHM AND NO CARDIOVERSION HAD BEEN DONE. THERE WERE NO ERRORS PRESENT FOR THE MAJORITY OF THE PROCEDURE. ERROR 257: BACK PATCH DETACH APPEARED TOWARDS THE END OF THE PROCEDURE. THE METAL VALUES WERE ALL WITHIN NORMAL RANGE. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE DOES NOT KNOW WHAT CAUSED THE MAP SHIFT. ADDITIONAL INFORMATION WAS RECEIVED. NO ERROR MESSAGE AS THE MAP SHIFT WAS DISCOVERED WHILE TRYING TO ABLATE AND WAS INSIDE A VEIN AND CLEARLY DID NOT MATCH CAM DATA. THE ISSUE WAS SEEN DURING ABLATING AND THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER THE MAP SHIFT WAS GREATER THAN 3MM. THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A MAP SHIFT WITH NO ERROR MESSAGE, NO PATIENT MOVEMENT AND NO CARDIOVERSION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284295 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC FG540000 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown