BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 19455508 · Received June 3, 2024

    Report

    Report Number
    2029046-2024-01797
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 8, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: ON 30-SEP-2024, IT WAS NOTICED THE INCORRECT PMA/ 510(K) NUMBER OF ¿K133916¿ WAS REPORTED IN THE 3500A INITIAL MEDWATCH REPORT UNDER FIELD G4. THE CORRECT NUMBER HAS NOW BEEN ADDED ¿K213264¿. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND NOISE ON ALL ECG SIGNALS OCCURRED. IT WAS REPORTED THAT THE ECG SIGNAL HAD BEEN NOISY AND WHEN MOVING THE ECG CABLE THE ISSUE REMAINED AND PUSHING ON THE SOCKET IT'S BETTER. THEY WERE NOT ABLE TO MAP SOMETIMES WHEN CHANGING CABLE OR CATHETER AS THE ISSUE REMAINED. THEY TRIED TO EXIT THE CASE AND REENTER IN THE CASE, TURNED OFF PIU AND WORKSTATION AND THE GENERATOR AND ULTIMATELY MANAGED TO FINISH THE CASE WIT THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE WAS INTERMITTENT AND HAPPENED DURING ABLATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE NOISE WAS OBSERVED ON BOTH BS + IC CHANNELS ON BOTH THE RECORDING AND CARTO® 3 SYSTEM. THE PHYSICIAN DID NOT HAVE ANY OTHER INTACT ECG SIGNALS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. AS SUCH, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION BASED ON THE NEW INFORMATION. DEVICE EVALUATION DETAILS: THE BIOSENSE WEBSTER INC (BWI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE BWI REPRESENTATIVE AND CONFIRMED THAT THE SIGNAL NOISE ISSUE WASN'T REPRODUCIBLE DURING ADDITIONAL PROCEDURES. REPLACEMENT BS ECG CABLE WAS SENT PER CUSTOMER'S REQUEST. THE SYSTEM IS READY FOR USE. THE SUSPECTED BS ECG CABLE WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. THE CABLE WAS TESTED BUT THE REPORTED ISSUE WAS NOT DUPLICATED. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM #11522 WAS REVIEWED. 1 SIMILAR COMPLAINT WAS FOUND. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #11522, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. NOTE: THE FULL UDI HAS NOW BEEN PROVIDED UNDER FIELD D4. PRIMARY UDI NUMBER. 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: ON 27-JUN-2024 IT WAS NOTICED THE INCORRECT DATE OF 5/8/2024 WAS REPORTED IN FIELD "G3. DATE RECEIVED BY MANUFACTURER" OF THE 3500A INITIAL MEDWATCH REPORT. PLEASE CONSIDER THE CORRECT DATE TO BE 5/14/2024. 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 NOISE ON ALL ECG SIGNALS OCCURRED. IT WAS REPORTED THAT THE ECG SIGNAL HAD BEEN NOISY AND WHEN MOVING THE ECG CABLE THE ISSUE REMAINED AND PUSHING ON THE SOCKET IT'S BETTER. THEY WERE NOT ABLE TO MAP SOMETIMES WHEN CHANGING CABLE OR CATHETER AS THE ISSUE REMAINED. THEY TRIED TO EXIT THE CASE AND REENTER IN THE CASE, TURNED OFF PIU AND WORKSTATION AND THE GENERATOR AND ULTIMATELY MANAGED TO FINISH THE CASE WIT THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE WAS INTERMITTENT AND HAPPENED DURING ABLATION. THE CUSTOMER¿S REPORTED NOISE ISSUE WAS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE RISK TO THE PATIENT IS LOW. HOWEVER, ON 14-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE NOISE WAS OBSERVED ON BOTH BS + IC CHANNELS ON BOTH THE RECORDING AND CARTO® 3 SYSTEM. THE PHYSICIAN DID NOT HAVE ANY OTHER INTACT ECG SIGNALS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. AS SUCH, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION BASED ON THE NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666414 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN CATHETER.| UNKNOWN ECG CABLE.| UNKNOWN GENERATOR.