BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3

    MDR report key: 21826886 · Received April 11, 2025

    Report

    Report Number
    2029046-2025-01119
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO 3 AND AS THE SYSTEM WAS STARTING UP, THE PATIENT INTERFACE UNIT (PIU) WAS CYCLING THROUGH THE NORMAL STEPS, AND NORMAL ERRORS WERE DISPLAYED AFTER BOOTING UP. SUDDENLY, THE PIU GREEN LIGHT TURNED RED, AND THE BACK PANEL LIGHT TURNED OFF. THEN, A LOUD NOISE BEGAN FROM THE PIU FAN "LIKE A PLANE WAS TAKING OFF", AND THERE WAS A SMELL LIKE BURNING PLASTIC. FIELD SERVICE ENGINEER ARRIVED AT THE ACCOUNT FOR TROUBLESHOOTING AND REPAIR AND RESOLVED THE ISSUE BY REPLACING THE PIU WITH ANOTHER ONE THAT WAS DELIVERED TO THE CUSTOMER. THE SUSPECTED PIU WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. DURING THE INVESTIGATION, THE "BURNING SMELL" ISSUE WAS NOT CONFIRMED AND NO SIGN OF BURNING SMELL WAS FOUND DURING INVESTIGATION. NO NOISES, ERRORS AND BURNING SIGNS WERE DETECTED. IN ADDITION, DURING VISUAL INSPECTION, CORROSION WAS DETECTED ON TWO ECG CARDS. IN ADDITION, DURING VISUAL INSPECTION, CORROSION WAS DETECTED ON TWO ECG CARDS. THE CORROSION FINDING IS NOT RELATED TO THE REPORTED 'BURNING SMELL' ISSUE. THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED AND NO MORE SIMILAR PROBLEMS WERE FOUND SINCE THE ISSUE OCCURRED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE CARTO 3 SYSTEM (SERIAL NUMBER (B)(6)), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. H4. DEVICE MANUFACTURE DATE WAS OBTAINED AND ADDED. THEREFORE, D4. PRIMARY UDI NUMBER WAS ALSO ADDED. H6. INVESTIGATION FINDINGS C19 IS ASSOCIATED TO NO FINDING TO THE REPORTED EVENT. C02 IS FOR THE ECG CARD CORROSION WHICH IS UNRELATED TO THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (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 AND AS THE SYSTEM WAS STARTING UP, THE PATIENT INTERFACE UNIT (PIU) WAS CYCLING THROUGH THE NORMAL STEPS, AND NORMAL ERRORS WERE DISPLAYED AFTER BOOTING UP. SUDDENLY, THE PIU GREEN LIGHT TURNED RED, AND THE BACK PANEL LIGHT TURNED OFF. THEN, A LOUD NOISE BEGAN FROM THE PIU FAN "LIKE A PLANE WAS TAKING OFF", AND THERE WAS A SMELL LIKE BURNING PLASTIC. THEY SHUT DOWN THE PIU, WITH ALL CABLES BEING DISCONNECTED. STARTED THE PIU ABOUT 4 TIMES, AND THE SAME ISSUE HAPPENED. THERE WERE NO ERRORS ON THE WORKSTATION. THE SYSTEM DID NOT RECOVER, AND THE CASE CONTINUE WITHOUT NAVIGATION. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SMELL WAS SPECIFICALLY ¿MELTING PLASTIC¿. THERE WERE NO SIGNS OF FIRE OR SMOKE. NO VISIBLE MELTING, JUST IDENTIFYING THE UNEXPECTED SMELL. NO KNOWN BLOWN FUSES OR ANY OTHER UNUSUAL ISSUES. NO EXPLICIT ERRORS ON THE CARTO WORKSTATION. BOOT UP SEQUENCE WAS AS EXPECTED, AND THE WORKSTATION NEVER SHUT DOWN. JUST PROGRESSED TO RED LIGHT ON FRONT OF PIU, BLACK LIGHTS ON BACK OF PIU, AND LOUD NOISE AND MELTING PLASTIC SMELL FROM INSIDE THE PIU. THEY TRIED RE-BOOTING MULTIPLE TIMES WITH SAME ISSUES PERSISTING. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2439583 CARTO 3 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_NGEN RF GENERATOR.