BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 6123338 · Received November 22, 2016

    Report

    Report Number
    3008203003-2016-00039
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 31, 2016
    Report Date
    October 31, 2016
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO 3 SYSTEM. IT WAS REPORTED THAT WHILE MAPPING WITH THE CARTO 3 SYSTEM, WHEN THE CATHETER WAS MOVED AND RETURNED TO A PREVIOUS LOCATION, THE LOCATION TAGS WERE MISALIGNED. THE POSITION OF THE CATHETER ON THE CARTO 3 SYSTEM AND FLUOROSCOPY WERE MISALIGNED. THERE WERE NO ERROR MESSAGES AND THE METAL VALUES WERE WITHIN NORMAL LIMITS. THE MAP SHIFT WAS ESTIMATED AT APPROXIMATELY 2.5 CM. IT WAS NOT KNOWN IF A CARDIOVERSION WAS PERFORMED OR IF THERE WAS PATIENT MOVEMENT TO EXPLAIN THE MAP SHIFT. THE PROCEDURE WAS COMPLETED USING THE SYSTEM WITH THIS ISSUE. THERE WERE NO PATIENT CONSEQUENCES. IT WAS REPORTED THAT THE CUSTOMER DECLINED REPAIR. THE SYSTEM WAS RETURNED TO CUSTOMER BY REQUEST OF THE CUSTOMER. IT WAS ALSO REPORTED THAT THE SYSTEM IS FUNCTIONAL. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES, WHICH ARE RELATED TO THE REPORTED ISSUE, WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO 3 SYSTEM. IT WAS REPORTED THAT WHILE MAPPING WITH THE CARTO 3 SYSTEM, WHEN THE CATHETER WAS MOVED AND RETURNED TO A PREVIOUS LOCATION, THE LOCATION TAGS WERE MISALIGNED. THE POSITION OF THE CATHETER ON THE CARTO 3 SYSTEM AND FLUOROSCOPY WERE MISALIGNED. THERE WERE NO ERROR MESSAGES AND THE METAL VALUES WERE WITHIN NORMAL LIMITS. THE MAP SHIFT WAS ESTIMATED AT APPROXIMATELY 2.5 CM. IT WAS NOT KNOWN IF A CARDIOVERSION WAS PERFORMED OR IF THERE WAS PATIENT MOVEMENT TO EXPLAIN THE MAP SHIFT. THE PROCEDURE WAS COMPLETED USING THE SYSTEM WITH THIS ISSUE. THERE WERE NO PATIENT CONSEQUENCES. THIS EVENT WAS ASSESSED AS A REPORTABLE MALFUNCTION AS SUCH MAP SHIFTS COULD POTENTIALLY BE CAUSED BY SYSTEM MALFUNCTION, AND THERE WOULD BE A POTENTIAL RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770905 CARTO® 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999 DQK BIOSENSE WEBSTER (ISRAEL) LTD. FG-5400-00K

    Patients

    Seq Age Sex Outcome Treatment
    1