BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 7979220 · Received October 18, 2018

    Report

    Report Number
    2029046-2018-02184
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 21, 2018
    Report Date
    September 21, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A CARTO® 3 SYSTEM AND WHEN A SECOND INDIFFERENT ELECTRODE WAS CONNECTED TO THE SMARTABLATE GENERATOR DURING RADIOFREQUENCY DELIVERY, A MAP SHIFT, NO ERROR MESSAGE, NO PATIENT MOVEMENT/CARDIOVERSION OCCURRED. THE INVESTIGATIONAL ANALYSIS COMPLETED 11/6/2018. THE BIOSENSE WEBSTER INC. (BWI) FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE BWI REPRESENTATIVE AND RECOMMENDED TO NOT CONNECT THE "BAYLIS" INDIFFERENT ELECTRODE INTO THE SMARTABLATE GENERATOR. THE RECOMMENDATION CORRECTED THE USER ERROR ISSUE. THE SYSTEM WAS READY FOR USE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES, WHICH WERE RELATED TO THE REPORTED ISSUE, WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. MANUFACTURER REF NO: (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. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A CARTO® 3 SYSTEM AND WHEN A SECOND INDIFFERENT ELECTRODE WAS CONNECTED TO THE SMARTABLATE GENERATOR DURING RADIOFREQUENCY DELIVERY, A MAP SHIFT OCCURRED. THE INDIFFERENT ELECTRODE WAS REMOVED, AND THE MAP SHIFT SEEMED TO CORRECT ITSELF. THE ELECTRODE WAS RECONNECTED AGAIN; IN STAND-BY MODE. THE MAP SHIFT OCCURRED AGAIN, MOVING THE MAP 1.5 CM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCES. THE MAP SHIFT ISSUE WAS SEEN DURING BOTH MAPPING AND ABLATING AND THE SYSTEM DID NOT DISPLAY ANY ERROR OR ALERT MESSAGES WHEN THE MAP SHIFT OCCURRED. THE MAP SHIFT WAS NOTICED BECAUSE THE LOCATION OF THE CORONARY SINUS CATHETER RELATIVE TO THE SNAPSHOT WAS OFF, AND THE LASSO WAS OUTSIDE OF THE PULMONARY VEIN SOUND CONTOUR. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT AND THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. THE MAP SHIFT, NO ERROR MESSAGE, NO PATIENT MOVEMENT/CARDIOVERSION ISSUES HAVE BEEN ASSESSED AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818233 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1