BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3041732 · Received April 8, 2013

    Report

    Report Number
    3008203003-2013-00045
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WAS A MAP SHIFT ON THE CARTO 3 SYSTEM WITHOUT ANY ERROR BEING DISPLAYED. ALSO, THERE WAS A RE-INITIALIZATION ERROR THAT WAS ACCEPTED. ONCE THE RE-INITIALIZATION ICON WAS SELECTED, IT WAS NOTICED THAT A MAP SHIFT HAS OCCURRED. IT WAS ALSO NOTED THAT THE V4 LEAD HAS EXPOSED WIRES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED. THE ISSUE WAS RELATED TO USER MISUNDERSTANDING OF CARTO SYSTEM BEHAVIOR. CARTO 3 SYSTEM MUST REPEAT THE INITIALIZATION PROCESS IN CASE OF ANY (BCS) BODY COORDINATE SYSTEM CHANGE. IN SUCH CASE, USER SHOULD BE PROMPTED TO BEGIN THE INITIALIZATION PROCESS. IN THIS SPECIFIC CASE, THE USER REPORTED THAT THE "REINITIALIZATION ERROR WAS ACCEPTED" AND THEN THE MAP SHIFT WAS OBSERVED. ACCEPTING THE SYSTEM PROMPT FOR "REINITIALIZATION" CAUSED THE BODY COORDINATE SYSTEM (BCS) RELEARN AND THE MAP SHIFT BECAME VISIBLE. IT WAS ALSO NOTED THAT THE V4 LEAD HAS EXPOSED WIRES. NEW CABLE WAS SENT TO ACCOUNT AND IT WAS INSTALLED UPON ARRIVAL. AN ADDITIONAL ORIGINAL EXTERNAL MANUFACTURER (OEM) ACTION THE DEVICE HISTORY RECORD REVIEW (DHR) WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WAS A MAP SHIFT ON THE CARTO 3 SYSTEM WITHOUT ANY ERROR BEING DISPLAYED. ALSO, THERE WAS A RE-INITIALIZATION ERROR THAT WAS ACCEPTED. ONCE THE RE-INITIALIZATION ICON WAS SELECTED, IT WAS NOTICED THAT A MAP SHIFT HAS OCCURRED. IT WAS ALSO NOTED THAT THE V4 LEAD HAS EXPOSED WIRES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144161 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1