BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 19366752 · Received May 21, 2024

    Report

    Report Number
    2029046-2024-01645
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 25, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K231207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS DISCOVERED. IT WAS REPORTED THAT THERE WERE SEVERAL MAP SHIFTS DURING THE CASE WHEN RF WAS TURNED ON. THE SYSTEM NEVER REINITIALIZED AND ALL PATCHES WERE ON THE SAME SPOT. NO PATIENT SHIFT. THE METAL VALUES WERE IN NORMAL RANGE. THE CALLER WAS ADVISED TO MOVE THE INDIFFERENT ELECTRODES FROM THE BACK TO THE PATIENT THIGHS. THE INDIFFERENT ELECTRODES WERE MOVED AND THE ISSUE RESOLVED. DEVICE EVALUATION DETAILS: AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER. AFTER REVIEWING THE RECEIVED DATA, IT WAS FOUND THAT THE REPORTED MAP SHIFT WAS CAUSED DUE TO MAPPING WITH HIGH METAL VALUES THAT WERE INDICATED ON THE SCREEN BY AN ERROR MESSAGE AND IN ADDITION BY PATIENT MOVEMENT. ISSUE IS RELATED TO USER ERROR. 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 ON CARTO 3 SYSTEM #(B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. CORRECTION: THE INCORRECT PMA/ 510(K) NUMBER OF ¿K133916¿ WAS REPORTED IN THE 3500A INITIAL MEDWATCH REPORT UNDER FIELD G4. THE CORRECT NUMBER HAS NOW BEEN ADDED ¿K231207¿. 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

    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 WAS DISCOVERED. IT WAS REPORTED THAT THERE WERE SEVERAL MAP SHIFTS DURING THE CASE WHEN RF WAS TURNED ON. THE SYSTEM NEVER REINITIALIZED AND ALL PATCHES WERE ON THE SAME SPOT. NO PATIENT SHIFT. THE METAL VALUES WERE IN NORMAL RANGE. THE CALLER WAS ADVISED TO MOVE THE INDIFFERENT ELECTRODES FROM THE BACK TO THE PATIENT THIGHS. THE INDIFFERENT ELECTRODES WERE MOVED AND THE ISSUE RESOLVED. ON 9-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NO ERROR ON THE SYSTEM. THE ISSUE WAS SEEN DURING ABLATING. THE MAP SHIFT WAS DISCOVERED BASED ON A VISUAL DISCREPANCY BETWEEN OUR ORIGINAL MAP AND WHERE OUR CATHETER WAS WHILE ABLATING THE CTI LINE. IT WAS DESCRIBED AS THE BOTTOM SOUND CONTOUR IS WHERE THE CTI LINE SHOWED UP WHEN WE REDREW IT FOLLOWING THE SHIFT. THIS THEN RESOLVED AFTER WE SWITCHED THE GROUNDING PADS TO THE THIGHS AND THE CATHETER WENT BACK TO NORMAL POSITION. THERE WAS NO CARDIOVERSION AND THE PATIENT DID NOT MOVE. THIS ISSUE HAPPENED SPONTANEOUSLY WITH NO ERRORS ONCE WE STARTED ABLATING. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 9-MAY-2024, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE IT WAS CONFIRMED THAT THERE WAS NO PATIENT MOVEMENT AND NO CARDIOVERSION DONE PRIOR TO THE MAP SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154775 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN NGEN SYSTEM