BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4372267 · Received December 30, 2014

    Report

    Report Number
    3008203003-2014-00082
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    December 12, 2014
    Report Date
    December 22, 2014
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REFERENCE #: (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND EXPERIENCED MAP SHIFT WITHOUT SYSTEM PROVIDING AN ERROR MESSAGE. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. ISSUE WAS NOT DUPLICATED. THE PROVIDED DATA IS LACK WITH INFORMATION, BASED ON THE AVAILABLE INFORMATION THE ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED. IN ADDITION THIS REPORT SUBMITTED FOR DOCUMENTATION PURPOSES ONLY. A FOLLOW UP WITH THE CUSTOMER INDICATED NO FURTHER MAP SHIFT INCIDENTS HAVE BEEN EXPERIENCED. THE CARTO SYSTEM CONTINUES TO WORK WELL. THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH CARTO 3 SYSTEM # (B)(4) WAS REVIEWED. OUT OF (B)(4) ADDITIONAL REPORTED COMPLAINTS THERE WAS NO ANY ADDITIONAL COMPLAINT THAT MAY BE RELATED TO THE REPORTED ISSUE. A DHR REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES 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 AND EXPERIENCED MAP SHIFT WITHOUT SYSTEM PROVIDING AN ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT IS BEING REPORTED BECAUSE ISSUE OF THIS TYPE COULD POTENTIALLY CONTRIBUTE TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860143 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1