BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 RMT SYSTEM

    MDR report key: 2902360 · Received January 8, 2013

    Report

    Report Number
    3008203003-2013-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WERE TWO ISSUES. THE NAVISTAR RMT THERMOCOOL CATHETER (LOT 15525380M) GAVE ISSUES WHEN ABLATING. AFTER ABOUT 9 SECONDS OF ABLATION, THE EP - SHUTTLE RF GENERATOR SYSTEM 100W GAVE AN ERROR MESSAGE "CATHETER ERROR" AND STOPPED ABLATING. IT DID SEVERAL TIMES IN A ROW. THE CATHETER WAS REPLACED BY ANOTHER NAVISTAR RMT THERMOCOOL CATHETER (LOT #: 15646237M). HOWEVER, THIS CATHETER COULD NOT BE SEEN ON THE CARTO 3 RMT SYSTEM OR ON THE RMT SYSTEM NAVIGANT. ERROR MESSAGES ON THE CARTO 3 RMT SYSTEM STATED "CATHETER MAGNETIC SENSOR DISCONNECTED" AND "NON-RMT CATHETER CONNECTED TO THE SYSTEM". BECAUSE OF THESE ERROR MESSAGES, THE PHYSICIAN SWITCHED FROM RMT PROCEDURE TO A REGULAR CARTO PROCEDURE WITH USING A REGULAR NAVISTAR CATHETER. THE PROCEDURE WAS INITIALLY CONTINUED FINE. IN THE NEXT CASE, THE USER USED A NEW CATHETER AND THE ISSUES WERE NOT DUPLICATED. IT WAS REPORTED THAT AFTER SWITCHING TO THE REGULAR CARTO 3 CASE, THE SYSTEM WORKED FINE AT THE BEGINNING. AFTER AWHILE, THE WORKSTATION FROZE AND THE PROCEDURE WAS CANCELLED. THE WORKSTATION WAS REPLACED AND TESTED WITH SIMULATOR. THE ISSUE WAS NOT DUPLICATED. THE WORKSTATION WAS REIMAGED AND SOFTWARE VERSION 2.3 WAS INSTALLED. IN ADDITION, THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH THIS SPECIFIC SYSTEM WERE REVIEWED AS WELL AND IT WAS FOUND THAT THERE WAS AN ADDITIONAL COMPLAINT RELATED TO THE REPORTED ISSUES. IN THIS COMPLAINT IT WAS DETERMINED AFTER TROUBLESHOOTING THAT THE RF ADAPTOR CABLE AND THE MAP ADAPTOR CABLE FOR RMT WERE DEFECTIVE, CAUSING AN ISSUE ON THE STOCKERT (CATHETER ERROR). THE MAP ADAPTOR CABLE AND RF ADAPTOR CABLE WERE REPLACED AND THE ISSUES WERE RESOLVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: EP - SHUTTLE RF GENERATOR SYSTEM 100W, MFG #: (B)(4), SERIAL #: (B)(4). NAVISTAR RMT THERMOCOOL, MFG#: (B)(4), LOT #: 15525380M, LOT #: 15646237M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WERE TWO ISSUES. FIRST, THE NAVISTAR RMT THERMOCOOL CATHETER (LOT 15525380M), GAVE ISSUES WHEN ABLATING. AFTER ABOUT 9 SECONDS OF ABLATION, THE EP - SHUTTLE RF GENERATOR SYSTEM 100W GAVE AN ERROR MESSAGE "CATHETER ERROR" AND STOPPED ABLATING. IT DID SEVERAL TIMES IN A ROW. THE CATHETER WAS REPLACED BY ANOTHER NAVISTAR RMT THERMOCOOL CATHETER (LOT #: 15646237M). HOWEVER, THIS CATHETER COULD NOT BE SEEN ON THE CARTO 3 RMT SYSTEM OR ON THE RMT SYSTEM NAVIGANT. ERROR MESSAGES ON THE CARTO 3 RMT SYSTEM STATED "CATHETER MAGNETIC SENSOR DISCONNECTED" AND "NON-RMT CATHETER CONNECTED TO THE SYSTEM". THESE PROBLEMS OF THE RMT CATHETERS WERE HIGHLY DETECTABLE AND THE RISK TO THE PATIENT WAS LOW, SO THIS ISSUE IS DEEMED NOT REPORTABLE. BECAUSE OF THESE ERROR MESSAGES, THE PHYSICIAN SWITCHED FROM RMT PROCEDURE TO A REGULAR CARTO PROCEDURE WITH USING A REGULAR NAVISTAR CATHETER. THE PROCEDURE WAS INITIALLY CONTINUED FINE, BUT AFTERWARDS THE CARTO 3 RMT SYSTEM FROZE. THEREFORE, THE PROCEDURE WAS CANCELLED. THE CASE CANCELLATION WAS ONLY BECAUSE OF THE CARTO ISSUE. THE PATIENT WAS IN GENERAL ANESTHESIA FOR 4 HOURS. THE TRANSSEPTAL PUNCTURE HAD ALREADY BEEN COMPLETED AND THE PROCEDURE WAS BEING PERFORMED IN THE LEFT ATRIUM. BUT THE PULMONARY VEINS WERE NOT ISOLATED. A SECOND PROCEDURE MIGHT HAVE TO BE SCHEDULED. THE PHYSICIAN DID NOT THINK THERE WAS ANY POTENTIAL RISK TO THE PATIENT DUE TO THIS MALFUNCTION. UPON RECEIPT OF THE CLARIFICATION OF THE CASE CANCELLATION INFORMATION ON (B)(6) 2013, THIS COMPLAINT WAS INDICATIVE OF A REPORTABLE EVENT, MARKING (B)(6) 2013, AS THE ALERT DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9038 CARTO 3 RMT SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-5830-01

    Patients

    Seq Age Sex Outcome Treatment
    1