BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3

    MDR report key: 20226671 · Received September 16, 2024

    Report

    Report Number
    2029046-2024-03100
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 20, 2024
    Report Date
    November 8, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K231207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4. PMA/ 510(K) - THIS FIELD HAS BEEN UPDATED WITH K231207. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PAROXYSMAL ABLATION PROCEDURE WITH A CARTO 3 AND MAPS SHIFTED DURING THE PROCEDURE, WITHOUT ERRORS DISPLAYED, AND WITHOUT PATIENT MOVEMENTS. THERE WAS NO APPARENT METAL IN THE FIELD. AFTER SUCCESSFULLY MAPPING THE RIGHT AND LEFT ATRIA, THEY PERFORMED ABLATIONS. WHEN BOTH CHAMBERS WERE RE-MAPPED, IT WAS NOTICED THAT THEY HAD "SHIFTED UPWARDS." THE REPORTER STATED THAT THE PATIENT WAS "JET VENTILATED" AND IT IS KNOWN THAT WHEN JET IS TURNED OFF THE MAP GOES TO A DIFFERENT LOCATION. HOWEVER, JET VENTILATION WAS NEVER STOPPED DURING PRE- AND POST-MAPPING IN THIS CASE. THEY STARTED NEW MAPS FOR BOTH CHAMBERS AFTER THE SHIFT WAS NOTICED AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: AN INVESTIGATION WAS INITIATED BY THE MANUFACTURER TO INVESTIGATE THE ISSUE. THE DATA WAS REQUESTED FOR AN INVESTIGATION; HOWEVER, NO FULL DATA WAS AVAILABLE TO INVESTIGATE THIS CASE SINCE THE WORKSTATION WAS REIMAGED. AS A RESULT, IT WAS NOT POSSIBLE TO REPRODUCE OR ANALYZE THE ISSUE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS NOT DETERMINED. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR AND ASSOCIATED WITH CARTO 3 SYSTEM # 34230 WAS REVIEWED. NO SIMILAR ADDITIONAL COMPLAINTS WERE FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE SYSTEM 34230, 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

    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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PAROXYSMAL ABLATION PROCEDURE WITH A CARTO 3 AND MAPS SHIFTED DURING THE PROCEDURE, WITHOUT ERRORS DISPLAYED, AND WITHOUT PATIENT MOVEMENTS. THERE WAS NO APPARENT METAL IN THE FIELD. AFTER SUCCESSFULLY MAPPING THE RIGHT AND LEFT ATRIA, THEY PERFORMED ABLATIONS. WHEN BOTH CHAMBERS WERE RE-MAPPED, IT WAS NOTICED THAT THEY HAD "SHIFTED UPWARDS." THE REPORTER STATED THAT THE PATIENT WAS "JET VENTILATED" AND IT IS KNOWN THAT WHEN JET IS TURNED OFF THE MAP GOES TO A DIFFERENT LOCATION. HOWEVER, JET VENTILATION WAS NEVER STOPPED DURING PRE- AND POST-MAPPING IN THIS CASE. THEY STARTED NEW MAPS FOR BOTH CHAMBERS AFTER THE SHIFT WAS NOTICED AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553868 CARTO 3 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 6FR CS,F,10 POLE,12 PIN,AUTOID| UNK CABLE| UNK_NGEN RF GENERATOR