BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 17878359 · Received October 5, 2023

    Report

    Report Number
    2029046-2023-02239
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 8, 2023
    Report Date
    January 1, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM. IT WAS REPORTED THAT THERE WAS A MAP SHIFT. THE ANATOMY WAS SHIFTED WITH THE POSITION OF THE CATHETER BUT THEY ARE SURE THEY DID NOT HAVE ANY. NO ERROR MESSAGE WAS SHOWN ON THE CARTO 3 SYSTEM. THEY CONTINUED LIKE THAT AS THE PHYSICIAN WAS VERY EXPERIENCED. PROCEDURE COMPLETED. NO PATIENT CONSEQUENCES. THE INVESTIGATION WAS COMPLETED ON (B)(6) 2023. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER CONFIRMED THAT THE WORKSTATION REIMAGED. ATP PASSED. SYSTEM OPERATIONAL. SERVICE COMPLETE. THE ISSUE WAS INVESTIGATED AT THE DEVICE MANUFACTURER UNDER AN INVESTIGATION REQUEST. THE ISSUE WAS NOT REPRODUCED IN THE DEVICE MANUFACTURER SQA LAB. NO ADDITIONAL INVESTIGATION CAN BE PERFORMED AS THE DATA RELATED TO THE ISSUE WAS NOT PROVIDED. IN ADDITION, THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH THIS SPECIFIC SYSTEM WAS REVIEWED AND IT WAS FOUND THAT THE ISSUE WAS NOT REPORTED ANYMORE. THE SYSTEM IS READY FOR USE. THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE SYSTEM # (B)(4), 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. 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)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND THERE WAS A MAP SHIFT WITH NO ERROR MESSAGE SHOWN ON THE CARTO 3 SYSTEM WITH NO PATIENT MOVEMENT OR CARDIOVERSION PERFORMED PRIOR TO THE SHIFT. INITIALLY IT WAS REPORTED THAT THERE WAS A MAP SHIFT. THE ANATOMY WAS SHIFTED WITH THE POSITION OF THE CATHETER BUT THEY ARE SURE THEY DID NOT HAVE ANY. THEY CONTINUED LIKE THAT AS THE PHYSICIAN WAS VERY EXPERIENCED. PROCEDURE COMPLETED. NO PATIENT CONSEQUENCES. NO DELAY. ERROR REPORT WAS MADE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2023. NO ERROR MESSAGE WAS SHOWN ON THE CARTO 3 SYSTEM. THE SHIFT WAS DISCOVERED BY THE DIFFERENCE IN CATHETER POSITION WHEN IT WAS POSITIONED IN THE PULMONARY VEINS. THERE WAS A MISMATCH OF THE ANATOMY WHICH WAS MADE WITH THE PENTARAY VERSUS THE VISUALIZATION OF THE SMARTTOUCH CATHETER. THE ISSUE WAS SEEN AFTER THE MAP WAS DONE AND BEFORE THE ABLATION PHASE STARTED. PHYSICIAN¿S WORKFLOW WAS TO DO A SINGLE TRANSSEPTAL (TSP) AND MAP THE ANATOMY WITH THE PENTARAY. AFTER, HE CHANGED THE CATHETER, HE INSERTED THE SMARTTOUCH CATHETER. THEREFORE, BOTH CATHETERS WERE NOT BOTH INSIDE AT THE SAME TIME. AFTER INSERTION OF THE SMARTTOUCH, HE POSITIONED IT INTO THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND DISCOVERED THAT THE SMARTTOUCH WAS VISUALIZED OUTSIDE THE VEIN. THEREFORE, HE TESTED SEVERAL OTHER PLACES TO VERIFY THE SHIFT AND IT WAS REPRODUCIBLE ON THE OTHER PLACES, TOO. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER THE MAP SHIFT SEEMED TO BE 0,5-1,0CM. THERE WAS NO PATIENT MOVEMENT OR CARDIOVERSION PRIOR TO THE SHIFT. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BIOSENSE WEBSTER INC. BECAME AWARE ON 12-SEP-2023 THAT THERE WAS NO ERROR MESSAGE SHOWN ON THE CARTO 3 SYSTEM WITH NO PATIENT MOVEMENT OR CARDIOVERSION PERFORMED PRIOR TO THE SHIFT AND HAVE REASSESSED THE MAP SHIFT EVENT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063461 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK SMARTTOUCH CATHETER.| UNK_PENTARAY.