BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3

    MDR report key: 23285251 · Received October 15, 2025

    Report

    Report Number
    2029046-2025-03430
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K231207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 19-NOV-2025, NOTED CORRECTIONS TO THE 3500A INITIAL AS IT WAS MISSING: - UNDER H11. ADDITIONAL MANUFACTURER NARRATIVE, "THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE." - UNDER G4. PMA/ 510(K): K231207. THE INVESTIGATION WAS COMPLETED ON 28-OCT-2025. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3. -IT WAS REPORTED THAT A 1003 ERROR ¿THE PATCH UNIT APPEARS DISCONNECTED¿ WAS DISPLAYED ON THE CARTO 3 SYSTEM WHEN ABLATING WITH THE FARAWAVE¿ PFA CATHETER. IT WAS CONFIRMED BY THE BIOSENSE WEBSTER FIELD REPRESENTATIVE THAT SINCE THE LAB WAS UNAVAILABLE, REPAIR DECLINED AT THAT TIME. SERVICE REJECTED BY CUSTOMER. AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. THE LOGS WERE REQUESTED IN ORDER TO INVESTIGATE THE ISSUE BUT NO DATA WAS RECEIVED SINCE THE CARTO 3 WORKSTATION WAS REIMAGED. IN ADDITION, 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. -IT WAS ALSO REPORTED THAT THERE WAS A MAP SHIFT WITH FARAWAVE CATHETER. WHEN PLACED THE OCTARAY CATHETER BACK ON THE LEFT ATRIUM, THE MAP SHIFT RESOLVED. IT WAS CONFIRMED THAT THE ISSUES WERE NOT DUPLICATED AFTERWARDS. AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. THE LOGS WERE REQUESTED IN ORDER TO INVESTIGATE THE ISSUE BUT NO DATA WAS RECEIVED SINCE THE CARTO 3 WORKSTATION WAS REIMAGED. IN ADDITION 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. -IT WAS ALSO REPORTED THAT AFTER OCTARAY CATHETER WAS CONNECTED THERE WAS NO IC SIGNALS ON THE CARTO 3 SYSTEM, ONLY ON RECORDING SYSTEM. IT WAS CONFIRMED THAT THE ISSUES WERE NOT DUPLICATED AFTERWARDS. AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. THE LOGS WERE REQUESTED IN ORDER TO INVESTIGATE THE ISSUE BUT NO DATA WAS RECEIVED SINCE THE CARTO 3 WORKSTATION WAS REIMAGED. IN ADDITION, 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. -IT WAS ALSO REPORTED THAT IT WAS NOT ABLE TO FAM WITH THE OCTARAY CATHETER. IT WAS CONFIRMED THAT THE ISSUES WERE NOT DUPLICATED AFTERWARDS. AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. THE LOGS WERE REQUESTED IN ORDER TO INVESTIGATE THE ISSUE BUT NO DATA WAS RECEIVED SINCE THE CARTO 3 WORKSTATION WAS REIMAGED. IN ADDITION, 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. -IT WAS ALSO NOTICED THAT THE SPU FIBER OPTIC CABLE WAS FRAYED. IT WAS CONFIRMED THAT THE ISSUE WAS RESOLVED BY REPLACING THE DAMAGED FIBER OPTIC CABLE WITH ANOTHER ONE THAT WAS DELIVERED TO THE CUSTOMER. THE SYSTEM IS READY FOR USE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR AND ASSOCIATED WITH CARTO SYSTEM # 10161 WAS REVIEWED. NO SIMILAR ADDITIONAL COMPLAINT WAS FOUND. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 #10161, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO COMPONENT FAILURE (D02) / COMPONENT CODE: OPTICAL FIBER (G05009) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿SPU FIBER OPTIC CABLE WAS FRAYED¿ ISSUE. IN ADDITION, BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿FIBER OPTIC CABLE¿. -INVESTIGATION FINDINGS: ELECTRICAL PROBLEM IDENTIFIED (C02) / INVESTIGATION CONCLUSIONS: CAUSE TRACED TO COMPONENT FAILURE (D02) / COMPONENT CODE: HUB (G02021) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿THE PATCH UNIT APPEARS DISCONNECTED¿ ISSUE. -INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿NO IC SIGNALS ON THE CARTO 3 SYSTEM,¿ ¿NOT ABLE TO FAM WITH THE OCTARAY CATHETER¿ AND ¿MAP SHIFT¿ ISSUES. D4. PRIMARY UDI NUMBER AND H4. DEVICE MANUFACTURE DATE HAVE BEEN ADDED. 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. 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 AND THERE WAS A MAP SHIFT WITH NO ERRORS SHOWN OR PROMPTS THAT WERE SPECIFICALLY RELATED TO THE MAP SHIFT, NO CARDIOVERSION PERFORMED PRIOR TO THE MAP SHIFT, AND NO PATIENT MOVEMENT BEFORE DETECTING THE SHIFT. IT WAS REPORTED THAT A 1003 ERROR ¿THE PATCH UNIT APPEARS DISCONNECTED¿ WAS DISPLAYED ON THE CARTO 3 SYSTEM WHEN ABLATING WITH THE FARAWAVE¿ PFA CATHETER. THEY NOTED THAT A MAP SHIFT OCCURRED. THE PHYSICIAN DID NOT WANT TROUBLESHOOTING ASSISTANCE AT THAT TIME AND THE CALLER DISCONNECTED THE CALL. THE CALLER CALLED BACK. THEY RESEATED THE PATCH UNIT CABLE AND THE ERROR CLEARED BUT REOCCURRED AFTER THE NEXT PULSE DELIVERY AND THEN THERE WAS AN OBVIOUS MAP SHIFT. THEY THEN PLACED THE OCTARAY CATHETER BACK ON THE LEFT ATRIUM AND THE MAP SHIFT RESOLVED BUT THEY DID NOT HAVE ANY ELECTROGRAMS ON THE CARTO 3 SYSTEM FROM THE OCTARAY CATHETER. THE ELECTROGRAMS WERE AVAILABLE ON THE GE RECORDING SYSTEM. THEY ALSO WERE NOT ABLE TO DO FAST ANATOMICAL MAPPING (FAM) WITH THE OCTARAY CATHETER. THEY WERE AT THE END OF THE PROCEDURE SO NO FURTHER TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THEY NOTICED THE SPU FIBEROPTIC CABLE WAS FRAYED. ADDITIONAL INFORMATION WAS RECEIVED ON 16-SEP-2025. ERRORS ON CARTO WERE THE PATCH UNIT ERROR (1003) AND ERROR 985. THAT 985 ERROR WOULD NOT CLEAR AND THE SPU LOADED UP GREEN ON THE FRONT EVERY TIME. IT WAS THE FARAWAVE NOT DISPLAYING PROPERLY ON THE MAP. THE FARAWAVE SHOWED UP CORRECTLY AFTER REMAPPING THE ENTIRE LEFT ATRIUM WITH OCTARAY TO ASSURE THE SHIFT WAS CORRECTED. WHEN PLACING FARAWAVE BACK IN THE BODY, THE SHIFT CORRECTED AND THEY FINISHED WITH THE PULSES. DURING THE POST MAP IS WHEN OCTARAY PROBLEMS WERE OCCURRING. NO SIGNAL ON THE CARTO 3 AND NO ERRORS OTHER THAN 985. SIGNAL ON PRUCA WAS SHOWING UP SO HE JUST USED THAT TO SEE IF THE VEINS WERE ISOLATED. PHOTO'S PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-SEP-2025. NO ERRORS SHOWN OR PROMPTS THAT WAS SPECIFICALLY RELATED TO THE MAP SHIFT. UNSURE OF THE EXACT DISTANCE. A CARDIOVERSION WAS NOT PERFORMED PRIOR TO THE MAP SHIFT. THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. THE PATIENT DID NOT COUGH BEFORE DETECTING THE SHIFT. THERE WERE NO CHANGES IN VENTILATION BEFORE THE MAP SHIFT. THE PATIENT¿S HEAD WAS NOT TOUCHED AT ALL, DID NOT MOVE AT ALL AND WAS NOT RAISED. THE PATIENT¿S ARM DID NOT MOVE. THE MAP SHIFT ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 17-SEP-2025 OF NO ERRORS SHOWN OR PROMPTS THAT WERE SPECIFICALLY RELATED TO THE MAP SHIFT, NO CARDIOVERSION PERFORMED PRIOR TO THE MAP SHIFT, AND NO PATIENT MOVEMENT BEFORE DETECTING THE SHIFT AND HAVE REASSESSED THE MAP SHIFT EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 17-SEP-2025. THE 1003 ERROR ¿THE PATCH UNIT APPEARS DISCONNECTED¿ ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THIS WAS HIGHLY DETECTABLE. THE ELECTROGRAM ISSUE WAS ASSESSED AS NON MDR REPORTABLE. IT IS NOT CONFIRMED THAT SIGNAL LOSS /NOISE OCCURRED ON BOTH CARTO AND EPRS, IT HAPPENED INTRA PROCEDURE, AND THE PHYSICIAN HAS CONFIRMED THAT THERE WAS AN EXTERNAL MONITOR TO WATCH THE PATIENT¿S ECG RHYTHM DURING THE NOISE ISSUE. UNABLE TO DO FAST ANATOMICAL MAPPING (FAM) WITH THE OCTARAY CATHETER ISSUE AND THE SPU FIBEROPTIC CABLE FRAYED ISSUE WERE BOTH ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH WAS REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190449 CARTO 3 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOSTON FARAWAVE PFA SYSTEM| FARAWAVE¿ PFA CATHETER| GE RECORDING SYSTEM| SPU FIBEROPTIC CABLE| UNK PATCH UNIT CABLE| UNK_OCTARAY NAV