BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 19539042 · Received June 14, 2024

    Report

    Report Number
    2029046-2024-01953
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 18, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 1-SEP-2024, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR RECIPROCATING TACHYCARDIA/WOLFF-PARKINSON-WHITE ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THAT PATIENT INTERFACE UNIT (PIU) GOT VERY NOISY AND THE DEVICE EMITTED A BURNING SMELL. THE GREEN LIGHT IN THE FRONT OF THE PIU ALSO TURNED OFF. THE MEDICAL TEAM CONFIRMED THE TEMPERATURE OF THE PIU WAS OK. NO PHYSICAL OR VISIBLE DAMAGES HAVE BEEN NOTICED ON THE PIU OR ANY OTHER COMPONENTS. THE MEDICAL TEAM TRIED TO TURN OFF THE PIU FOR 10 MINUTES AND TURNED IT ON AGAIN AFTER, BUT THE SAME ISSUE REMAINED (NOISE, BURN SMELL AND NO LIGHT INDICATOR). AS TEMPORARY SOLUTION, THEY SET UP NEW ELECTRODES AND FINISH THE PROCEDURE CONVENTIONALLY (WITHOUT PIU). NO PATIENT CONSEQUENCES WERE REPORTED. THERE WAS A 20-30 MINUTES DELAY REPORTED DUE TO TROUBLESHOOTING. DEVICE EVALUATION DETAILS: IT WAS CONFIRMED THAT THE ISSUE WAS RESOLVED BY REPLACING THE FAULTY PIU (PATIENT INTERFACE UNIT) WITH ANOTHER ONE THAT WAS DELIVERED TO THE CUSTOMER. THE SUSPECTED PIU/LP WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. IT WAS FOUND THAT THE ISSUE WAS CAUSED BY A DEFECTIVE COMPONENT PLACED ON DC/DC CARD (DIRECT CURRENT) REPLACING THE DEFECTIVE COMPONENT ON THE DC/DC CARD RESOLVED THE ISSUE . THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 #(B)(6), 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

    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. 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 ATRIOVENTRICULAR RECIPROCATING TACHYCARDIA/WOLFF-PARKINSON-WHITE ABLATION PROCEDURE WITH A CARTO 3 SYSTEM AND THAT PATIENT INTERFACE UNIT (PIU) GOT VERY NOISY AND THE DEVICE EMITTED A BURNING SMELL. THE GREEN LIGHT IN THE FRONT OF THE PIU ALSO TURNED OFF. THE MEDICAL TEAM CONFIRMED THE TEMPERATURE OF THE PIU WAS OK. NO PHYSICAL OR VISIBLE DAMAGES HAVE BEEN NOTICED ON THE PIU OR ANY OTHER COMPONENTS. THE MEDICAL TEAM TRIED TO TURN OFF THE PIU FOR 10 MINUTES AND TURNED IT ON AGAIN AFTER, BUT THE SAME ISSUE REMAINED (NOISE, BURN SMELL AND NO LIGHT INDICATOR). AS TEMPORARY SOLUTION, THEY SET UP NEW ELECTRODES AND FINISH THE PROCEDURE CONVENTIONALLY (WITHOUT PIU). NO PATIENT CONSEQUENCES WERE REPORTED. THERE WAS A 20-30 MINUTES DELAY REPORTED DUE TO TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389957 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown