BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 21414248 · Received February 19, 2025

    Report

    Report Number
    2029046-2025-00468
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    January 22, 2025
    Report Date
    March 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. 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

    ON 16-MAR-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A CARTO 3 SYSTEM AND THE PHYSICIAN ASSISTANT EXPERIENCED ELECTRICAL SHOCK. DEVICE EVALUATION DETAILS: FIELD SERVICE ENGINEER ARRIVED AT THE ACCOUNT FOR TROUBLESHOOTING AND REPAIR. IT WAS FOUND THAT THE LOCATION PAD CABLE AND LOCATION PAD EXTENSION CABLE WERE PHYSICALLY DAMAGED. IT WAS CONFIRMED THAT THE DAMAGED LOCATION PAD CABLE AND LOCATION PAD EXTENSION CABLE WERE REPLACED AND THE ISSUE WAS RESOLVED. THE DAMAGED LOCATION PAD CABLE AND LOCATION PAD EXTENSION CABLE ASSOCIATED WITH THIS COMPLAINT ARE NOT AVAILABLE FOR INVESTIGATION SINCE THEY WERE DISCARDED BY THE ACCOUNT. THEREFORE THE COMPLAINT ANALYSIS CONCLUSION IS BASED ON THE AVAILABLE INFORMATION. THE SYSTEM IS READY FOR USE. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 # (B)(6), AND NO INTERNAL ACTIONS RELATED TO THE REPORTED ISSUE 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A CARTO 3 SYSTEM AND THE PHYSICIAN ASSISTANT EXPERIENCED ELECTRICAL SHOCK. WHEN THE PHYSICIAN ASSISTANT (PA) DISCONNECTED THE LOCATION PAD, THE PHYSICIAN'S ASSISTANT WAS ELECTROCUTED. THE PHYSICIAN ASSISTANT FELT A "ZAP" AND DROPPED THE LOCATION PAD CABLES. NO MEDICAL INTERVENTION WAS PROVIDED TO THE PA. AFTER THE EVENT, THE PA SCRUBBED INTO THE ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATION) CASE. THE PA WAS ASKED IF HIS HANDS WERE WET, AND HE STATED HE WAS WEARING GLOVES. THE LAST KNOWN STATUS WAS THAT THE PA WAS STABLE. THE LOCATION PAD WAS DISCONNECTED FROM THE CARTO 3 SYSTEM'S PIU (PATIENT INTERFACE UNIT) AT THE TIME OF THE EVENT. ALL BWI PRODUCTS WERE DISCONNECTED AT THE TIME OF THE EVENT. CARTO 3 SYSTEM WAS TESTED AND THERE WERE NO ISSUES. THE SITUATION OCCURRED AFTER THE PROCEDURE AND THE PATIENT WAS ALREADY OUT OF THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74067 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PFA BOSTON SCIENTIFIC SYSTEM.