BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 18851542 · Received March 6, 2024

    Report

    Report Number
    2029046-2024-00752
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    January 29, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DUE TO A REPORTABLE LAB FINDING UNDER THE CONCOMITANT PRODUCT THMCL SMTCH SF BID, TC, D-F ON (B)(6) 2024, PROCESSED H10. RELATED REPORT NUMBER FIELD. 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 INVESTIGATION WAS COMPLETED ON 05-MAY-2024. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM. IT WAS REPORTED THAT THEY HAD A MAP SHIFT WITHOUT ANY WARNING OR ALERT. IT WAS VERIFIED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THERE WAS A MAP SHIFT AND THEY HAD TO MAKE A NEW MAP. NO CARDIOVERSION OR PATIENT MOVEMENT BEFORE THE SHIFT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. IT WAS FOUND THAT THE REPORTED 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. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 # 004203, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. H6. COMPONENT CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (G07002)¿ REPRESENTS 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 AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT WITH NO ERROR MESSAGE/WARNING/ALERT, NO CARDIOVERSION PERFORMED AND NO PATIENT MOVEMENT ISSUE OCCURRED. INITIALLY IT WAS REPORTED THAT THEY HAD A MAP SHIFT WITHOUT ANY WARNING OR ALERT. IT WAS VERIFIED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THERE WAS A MAP SHIFT AND THEY HAD TO MAKE A NEW MAP. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2024. NO ERROR SEEN. MAP SHIFT WAS CONFIRMED USING ICE. ISSUE SEEN DURING ABLATION. APPROXIMATE DISTANCE WAS MORE THAN 1 CM. NO CARDIOVERSION OR PATIENT MOVEMENT BEFORE THE SHIFT. THIS MAP SHIFT WITH NO ERROR/WARNING/ALERT EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THERE WAS NO CARDIOVERSION OR PATIENT MOVEMENT BEFORE THE SHIFT ON 12-FEB-2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477190 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown THMCL SMTCH SF BID, TC, D-F| UNK CABLE