BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 10453951 · Received August 26, 2020

    Report

    Report Number
    2029046-2020-01110
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 28, 2020
    Report Date
    July 28, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 10/28/2020: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM. DURING THE PROCEDURE YESTERDAY, WHILE MAPPING, A MAP SHIFT WAS OBSERVED ON THE CARTO® 3 SYSTEM. THIS OCCURRED MIDWAY THROUGH THE PROCEDURE AFTER COMPLETION OF CRYO ABLATION ON THE LEFT VEINS AND THEY MOVED TO THE RIGHT VEINS WHICH THERE WAS AN OBVIOUS AND SIGNIFICANT SHIFT OF ROUGHLY 20 MM FROM PRE FAST ANATOMICAL MAPPING (FAM) AND POST FAM WAS OBSERVED. THERE WERE NO ERROR CODES OR LEARN NEW MESSAGES BEING DISPLAYED. THE PATCHES WERE CHECKED AND WERE FOUND TO BE IN THE SAME POSITION. THE MAP SHIFT WAS NOTICED WITHIN ADVANCED CATHETER LOCATION (ACL) TOLERANCE WITHIN MATRIX. THERE WAS NO CARDIOVERSION NOR PATIENT MOVEMENT PRIOR TO THE MAP SHIFT. A NEW MAP WAS CREATED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THE BIOSENSE WEBSTER, INC. FIELD SERVICE REPRESENTATIVE SPOKE TO THE BIOSENSE WEBSTER, INC. REPRESENTATIVE AND WAS ADVISED THAT THEY INITIALIZED THE SYSTEM PRIOR TO THE FLUOROSCOPY SYSTEM BEING IN THE FIELD. THIS LED TO INCREASED METAL INTERFERENCE CAUSING A MAP SHIFT. USER ERROR IN THE HARDWARE SETUP CAUSED THE ISSUE. SYSTEM IS OPERATIONAL. DATA RELATED TO THE REPORTED ISSUE WAS SENT TO THE DEVICE MANUFACTURER FOR INVESTIGATION. THE ISSUE WAS INVESTIGATED AT BY THE DEVICE MANUFACTURER. THE ISSUE WAS NOT REPRODUCED IN THE DEVICE MANUFACTURER SQA LAB. NO ADDITIONAL INVESTIGATION CAN BE PERFORMED AS THE DATA RELATED TO THE ISSUE ARRIVED WITHOUT RECORDINGS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE CARTO 3 SYSTEM #12500, 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 · 1

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED WITH NO ERROR MESSAGE AND NO PATIENT MOVEMENT AND NO CARDIOVERSION. DURING THE PROCEDURE YESTERDAY, WHILE MAPPING, A MAP SHIFT WAS OBSERVED ON THE CARTO® 3 SYSTEM. THIS OCCURRED MIDWAY THROUGH THE PROCEDURE AFTER COMPLETION OF CRYO ABLATION ON THE LEFT VEINS AND THEY MOVED TO THE RIGHT VEINS WHICH THERE WAS AN OBVIOUS AND SIGNIFICANT SHIFT OF ROUGHLY 20 MM FROM PRE FAST ANATOMICAL MAPPING (FAM) AND POST FAM WAS OBSERVED. THERE WERE NO ERROR CODES OR LEARN NEW MESSAGES BEING DISPLAYED. THE PATCHES WERE CHECKED AND WERE FOUND TO BE IN THE SAME POSITION. THE MAP SHIFT WAS NOTICED WITHIN ADVANCED CATHETER LOCATION (ACL) TOLERANCE WITHIN MATRIX. THERE WAS NO CARDIOVERSION NOR PATIENT MOVEMENT PRIOR TO THE MAP SHIFT. A NEW MAP WAS CREATED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THE REPORTED MAP SHIFT WITH NO ERROR MESSAGE AND NO PATIENT MOVEMENT AND NO CARDIOVERSION WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921746 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC FG540000 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BRAND CRYO ABLATION CATHETER| UNKNOWN BRAND PATCHES