BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 15161430 · Received August 3, 2022

    Report

    Report Number
    2029046-2022-01783
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 11, 2022
    Report Date
    April 26, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO CARTO® 3 SYSTEM APPROVED UNDER 510K # K042999. 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 4. 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).

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME (CONT): (B)(6). ADDITIONAL INFORMATION WAS RECEIVED ON 05-AUG-2022. IT WAS REPORTED THAT THE FACILITY NAME IS (B)(6) HOSPITAL AFFILIATED TO (B)(6). THEREFORE, E 1. INITIAL REPORTER FACILITY NAME WAS UPDATED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-AUG-2022. IT WAS REPORTED THAT ANALOG SHIFT POSITION, BODY SURFACE INTERFERENCE. THE MACHINE SOFTWARE VERSION IS NOT AVAILABLE. 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 WAS COMPLETED ON 28-MAR-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. AN INVESTIGATION WAS INITIATED BY THE DEVICE MANUFACTURER TO INVESTIGATE THE ISSUE. THE STUDY DATA WAS REQUESTED TO INVESTIGATE THE ISSUE. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE REPORTED THAT THE DATA IS NOT AVAILABLE. INVESTIGATION OF CARTO MAP SHIFT WAS NOT POSSIBLE. THE BWI FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE ACCOUNT AND CHECKED THE SYSTEM AND ALL VALUES WERE OKAY. THE BWI REPRESENTATIVE CONFIRMED THAT DURING THE PROCEDURE, NO CARDIOVERSION WAS PERFORMED AND THE PATIENT DID NOT MOVE. FSE STATED THAT HE WAS UNABLE TO DETECT MAP SHIFT DUE TO NO SURGERY. FSE CONFIRMED THAT THE PATCH UNIT WAS REPLACED WITH A NEW ONE THAT WAS DELIVERED TO THE CUSTOMER. THERE WAS NO MAP SHIFT OCCURRED, AND THE SYSTEM IS READY FOR USE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM # 6067260 WAS REVIEWED. NO SIMILAR COMPLAINTS WERE FOUND. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE CARTO 3 SYSTEM #6067260, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. BASED ON THE MRE, THE H4. DEVICE MANUFACTURE DATE WAS UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. IT WAS REPORTED THAT AN ANALOG SHIFT, BODY SURFACE INTERFERENCE OCCURRED. THE SYSTEM DID NOT REPORT AN ERROR. AFTER CATHETER ABLATION, THE WALL WENT TO THE TOP, AND IT WAS FOUND THAT IT EXCEEDED THE MODEL. THE MODEL MOVES WITHOUT THE PATIENT MOVING. THE LEFT SUPERIOR PULMONARY VEIN IS ABOUT ONE ELECTRODE AWAY. NO CARDIOVERSION WAS PERFORMED, AND THE PATIENT DID NOT MOVE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THIS WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081657 CARTO® 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999 DQK BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown