BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 18071954 · Received November 6, 2023

    Report

    Report Number
    2029046-2023-02542
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 6, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED, THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE. WITH A CARTO® 3 SYSTEM. AND SMOKE SMELL WAS PRESENT. IT WAS REPORTED, THAT THE BWI REPRESENTATIVE SMELLED SMOKE. THE CHEST PATCH SENSOR CABLE JUST PROXIMAL TO THE CONNECTOR TO THE PATIENT INTERFACE UNIT (PIU) WAS MELTED. THE BWI REPRESENTATIVE, REQUEST BWI FIELD SERVICE ENGINEER FOLLOW UP AND REPLACE THE YELLOW SENSOR CABLE. THERE WERE NO VISIBLE FIRE OR FLAMES AND NO VISIBLE SMOKE. IT WAS THE SMELL OF MELTED PLASTIC THAT WAS PRESENT THOUGH. DEVICE EVALUATION DETAILS: IT WAS CONFIRMED, BY THE BWI REPRESENTATIVE. THAT THE ISSUE WAS RESOLVED, BY REPLACING THE CHEST PATCH SENSOR CABLE WITH ANOTHER ONE THAT WAS DELIVERED TO THE CUSTOMER. NO TESTS OR CHECK WAS REQUIRED FOR THE CARTO 3 SYSTEM. SYSTEM FUNCTIONS AND IS OPERATIONAL AT THE SAME ACCOUNT. THE SYSTEM IS READY FOR USE. THE SUSPECTED CHEST PATCH SENSOR CABLE WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. THE CABLE WAS TESTED AND PASSED ALL TESTS. THERE WAS NO SMOKE SMELL FROM THE CABLE/CONNECTOR. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED, DURING THE LAST YEAR AND ASSOCIATED WITH CARTO 3 SYSTEM WITH SERIAL#: (B)(6) WAS REVIEWED. NO SIMILAR ADDITIONAL COMPLAINT WAS FOUND. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 WITH SERIAL#:(B)(6). AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE COMPLAINT INVESTIGATION RESULTS WILL BE USED FOR MONITORING AND DETECTING STATISTICAL SIGNALS, PER COMPLAINT TRENDING AND SIGNAL DETECTION PROCESS. NO CAPA IS INITIATED, AS THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, DO NOT MEET THE CAPA TRIGGERS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. (B)(4).

    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

    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 REF.(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 SYSTEM AND SMOKE SMELL WAS PRESENT. IT WAS REPORTED THAT THE BWI REPRESENTATIVE SMELLED SMOKE. THE CHEST PATCH SENSOR CABLE JUST PROXIMAL TO THE CONNECTOR TO THE PATIENT INTERFACE UNIT (PIU) WAS MELTED. THE BWI REPRESENTATIVE REQUEST BWI FIELD SERVICE ENGINEER FOLLOW UP AND REPLACE THE YELLOW SENSOR CABLE. THERE WERE NO VISIBLE FIRE OR FLAMES AND NO VISIBLE SMOKE. IT WAS THE SMELL OF MELTED PLASTIC THAT WAS PRESENT THOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953237 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown