BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 19374521 · Received May 22, 2024

    Report

    Report Number
    2029046-2024-01665
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 25, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K213264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 22-MAY-2024, NOTED A CORRECTION TO THE 3500A INITIAL AS MISSING H4. DEVICE MANUFACTURE DATE. THEREFORE, ADDED 07-OCT-2012. 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

    THE PRODUCT INVESTIGATION WAS REOPENED TO CLARIFY/CORRECT THE INVESTIGATION FINDINGS WHICH RESULTED IN THE FOLLOWING UPDATED INVESTIGATION ON 20-JUL-2024. THE MANUFACTURER INVESTIGATED THE ISSUE. IT WAS FOUND THAT THE REPORTED MAP SHIFT WAS CAUSED DUE TO METAL INTERFERENCE (HIGH METAL VALUES) WHILE MAPPING. IT WAS CONFIRMED THAT THE SYSTEM DISPLAYED THE RELATED ERROR MESSAGES ON THE SCREEN. ACCORDING TO THE CARTO 3 INSTRUCTIONS FOR USE, METAL INTERFERENCE MIGHT AFFECT LOCATION ACCURACY. IN ADDITION, THE BIOSENSE WEBSTER, INC. FIELD SERVICE ENGINEER TALKED TO BIOSENSE WEBSTER, INC. REPRESENTATIVE, WHO CONFIRMED THAT THE SYSTEM WAS OKAY, AND IT DOES NOT REQUIRE ANY SERVICE. THEREFORE, THE ISSUE IS DEFINED AS USER RELATED. THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED AND NO MORE SIMILAR PROBLEMS WERE FOUND SINCE THE ISSUE OCCURRED. THE SYSTEM IS READY FOR USE. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #12575, AND NO NON-CONFORMITIES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. DURING AN INTERNAL REVIEW ON 15-AUG-2024, NOTED A CORRECTION TO THE 3500A INITIAL "G4. PMA/ 510(K)" FIELD. SHOULD HAVE BEEN K213264. THEREFORE, PROCESSED ACCORDINGLY. 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

    THE INVESTIGATION WAS COMPLETED ON 19-MAY-2024. THE BIOSENSE WEBSTER, INC. (BWI) FIELD SERVICE ENGINEER FOLLOWED UP WITH THE BWI REPRESENTATIVE AND CONFIRMED THAT THE SYSTEM IS FUNCTIONAL. IN ADDITION, AN INVESTIGATION WAS INITIATED BY THE DEVICE MANUFACTURER TO INVESTIGATE THE ISSUE. AFTER REVIEWING THE RECEIVED DATA, IT WAS FOUND THAT THE REPORTED MAP SHIFT WAS CAUSED DUE TO MAPPING WITH HIGH METAL VALUES THAT WERE INDICATED ON THE SCREEN BY AN ERROR MESSAGE. ISSUE IS RELATED TO USER ERROR. THE COMPLAINT HISTORY OF THE SYSTEM WAS REVIEWED AND NO MORE SIMILAR PROBLEMS WERE FOUND SINCE THE ISSUE OCCURRED. THE SYSTEM IS READY FOR USE. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED ON CARTO 3 SYSTEM #12575, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. H6. COMPONENT CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (G07002)¿ REPRESENTS MAP SHIFT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED WITH NO ERROR MESSAGE NOR PATIENT MOVEMENT. IT WAS REPORTED THAT THEY HAD A MAP SHIFT WITHOUT ANY ALERTS, ERROR MESSAGE, WARNINGS, OR PATIENT MOVEMENT. THEY DID A SECOND MAP AND THE ISSUE REMAINED, WHEN THEY SWITCHED FROM ONE MAP TO ANOTHER, ONCE AGAIN WITHOUT ANY ALERTS, ERROR MESSAGE, WARNINGS, OR PATIENT MOVEMENT. THEY USED THE PENTARAY CATHETER TO COMPARE THE FIRST AND SECOND MAP AND THEY CONCLUDED THE FIRST MAP WAS THE RIGHT ONE. AFTER THAT THEY TURNED ON/OFF THE PATIENT INTERFACE UNIT (PIU) AND THE WORKSTATION, REOPENED THE SAME STUDY AND THE ISSUE WAS STILL THERE. THEY HAD THE SAME WITH THE SMARTTOUCH SF CATHETER ON THE DISTAL ELECTRODES LATER DURING THE PROCEDURE. THEY HAD NOT TROUBLESHOOTED OR REMAPPED, THEY CONTINUED WITH THE ISSUE. PROCEDURE WAS COMPLETED WITH DIFFICULTIES BUT THEY TREATED THE PATIENT LIKE THEY WANTED. NO PATIENT CONSEQUENCES. THERE WAS ONE HOUR DELAY REPORTED DUE TO THE TROUBLESHOOTING AND THE ISSUES. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750329 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERIC - PENTARAY| SMARTTOUCH SF CATHETER