BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5086371 · Received September 17, 2015

    Report

    Report Number
    3008203003-2015-00077
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND A PROCEDURE DELAY OCCURRED. THE CARTO 3 SYSTEM WAS DISPLAYING ERROR 17 LOCATION PAD CURRENTS UNSTABLE. THEY REBOOTED THE PATIENT INTERFACE UNIT (PIU) WITHOUT RESOLUTION. THEY TURNED OFF THE PIU AND DISCONNECTED AND RECONNECTED THE LOCATION PAD (LP) EXTENSION CABLE FROM THE BACK OF THE PIU AND THE SAME ON THE LP END OF THE EXTENSION CABLE. THEY POWERED ON THE PIU AND ERROR 17 RETURNED. THEY THEN TURNED OFF THE PIU AND CONNECTED THE LP DIRECTLY TO THE PIU. WHEN THE PIU BOOTED UP, THE ERROR 17 RETURNED. THEY REBOOTED THE PIU AND THE WORKSTATION. THE PIU WAS CYCLING FROM 1, 2, AND THEN BACK TO 1. THE USE OF THE CARTO 3 SYSTEM WAS ABORTED AS THE CARTO 3 SYSTEM ISSUES COULD NOT BE RESOLVED. HOWEVER, THE PROCEDURE WAS CONTINUED WITH THE USE OF CRYO. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER ARRIVED TO THE ACCOUNT AND WAS ABLE TO DUPLICATE THE REPORTED COMPLAINT. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER DISCOVERED THAT THE FAULTY LP EXTENSION CABLE CAUSED THE REPORTED ISSUE. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER PLACED AN ORDER FOR THE LP EXTENSION CABLE. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER FOLLOWED UP ON THE ISSUE WITH THE BIOSENSE WEBSTER FIELD REPRESENTATIVE AND CONFIRMED THAT THE REPLACEMENT LP EXTENSION CABLE WAS DELIVERED TO THE ACCOUNT AND RESOLVED THE ISSUE. THE SYSTEM IS READY FOR USE. THE DEVICE HISTORY RECORD (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 (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM AND A PROCEDURE DELAY OCCURRED. THE CARTO 3 SYSTEM WAS DISPLAYING ERROR 17 LOCATION PAD CURRENTS UNSTABLE. THEY REBOOTED THE PATIENT INTERFACE UNIT (PIU) WITHOUT RESOLUTION. THEY TURNED OFF THE PIU AND DISCONNECTED AND RECONNECTED THE LOCATION PAD (LP) EXTENSION CABLE FROM THE BACK OF THE PIU AND THE SAME ON THE LP END OF THE EXTENSION CABLE. THEY POWERED ON THE PIU AND ERROR 17 RETURNED. THEY THEN TURNED OFF THE PIU AND CONNECTED THE LP DIRECTLY TO THE PIU. WHEN THE PIU BOOTED UP, THE ERROR 17 RETURNED. THEY REBOOTED THE PIU AND THE WORKSTATION. THE PIU WAS CYCLING FROM 1, 2, AND THEN BACK TO 1. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR APPROXIMATELY 30 MINUTES. A TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED. THE USE OF THE CARTO 3 SYSTEM WAS ABORTED AS THE CARTO 3 SYSTEM ISSUES COULD NOT BE RESOLVED. HOWEVER, THE PROCEDURE WAS CONTINUED WITH THE USE OF CRYO. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE PROCEDURE DELAY HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION BASED ON THE FACTS THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA, THERE WAS AS TRANSSEPTAL PUNCTURE, AND THERE WAS ASSESSED PHYSICIAN RISK. ON ATTEMPTING TO CLARIFY THE PHYSICIAN RISK OPINION, INFORMATION WAS PROVIDED WHICH INDICATES THAT THE ASSESSED RISK MAY BE DUE TO A CUSTOMER PREFERENCE REGARDING THE LOCATION PAD. AS SUCH, THIS ASSESSMENT IS CONSERVATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617062 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1