BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2840750 · Received November 20, 2012

    Report

    Report Number
    3008203003-2012-00060
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AFIB - PAROXYSMAL PROCEDURE AS SOON AS THE THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS CONNECTED TO THE CARTO 3 SYSTEM, THEY EXPERIENCED EXTREME INTERFERENCE ON ALL BODY SURFACE(BS) ECG'S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE GE RECORDING SYSTEM AND THE CARTO 3 SYSTEM, AS WELL AS AN ERROR 8 (PACING ROUTING IS DISABLED) DISPLAYED ON THE CARTO 3 SYSTEM. THERE WAS NO PATIENT INJURY REPORTED. THE BWI FIELD SERVICE ENGINEER REPORTED THAT WHEN THE CUSTOMER CONNECTED BACK THE THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER AFTER THE CASE, THE ERROR DID NOT REAPPEAR. A FAULTY BODY SURFACE (BS) ECG CABLE CAUSED THE ISSUE. A REPLACEMENT BS ECG CABLE WAS SENT TO THE ACCOUNT. THE BWI FIELD SERVICE ENGINEER RECEIVED A CONFIRMATION FROM THE CUSTOMER THAT THE NEW BS ECG CABLE ARRIVED AND WAS FITTED. THE BS ECG CABLE REPLACEMENT RESOLVED THE ISSUE. THE ISSUE WAS NOT SEEN IN THE NEXT CASE. IN ADDITION, THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH THIS SPECIFIC SYSTEM WAS REVIEWED AND THE ISSUE HAS NOT BEEN REPORTED AGAIN. THE SYSTEM IS OPERATIONAL. AN ADDITIONAL OEM MANUFACTURER ACTION DEVICE HISTORY RECORD (DHR) WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCT: THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER, MODEL #: D-1327-05-S, LOT #:UNKNOWN. THIS CATHETER HAS NOT BEEN APPROVED BY US FDA AND IS NOT MARKETED IN THE US THEREFORE THIS COMPLAINT IS NOT MDR REPORTABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB - PAROXYSMAL PROCEDURE AN ERROR 8 WAS ENCOUNTERED. THERE WAS NO PATIENT INJURY REPORTED. UPON FURTHER FOLLOW-UP WITH THE BWI FIELD REPRESENTATIVE ON (B)(6) 2012, IT WAS STATED AS SOON AS THE THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS CONNECTED TO THE CARTO 3 SYSTEM, THEY EXPERIENCED EXTREME INTERFERENCE ON ALL BODY SURFACE(BS) ECG'S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE GE RECORDING SYSTEM AND THE CARTO 3 SYSTEM, AS WELL AS AN ERROR 8 (PACING ROUTING IS DISABLED) DISPLAYED ON THE CARTO 3 SYSTEM. THE SYSTEM ADVISED TO SWITCH OFF THE POWER SUPPLY TO THE PATIENT INTERFACE UNIT (PIU) AND THEN SWITCH ON AGAIN. THIS SEEMED TO HELP INITIALLY BUT THEN IT WAS THEN NOTED THAT THERE WAS NO IMPEDANCE VALUE SEEN ON THE STOCKERT 70 SYSTEM AND ONLY 5 DEGREES TEMPERATURE WAS REFLECTING. AFTER CHANGING ALL THE CONNECTION CABLES TO THE THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THE STOCKERT 70 SYSTEM WITH NO RESOLVE, THE THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER WAS REMOVED AND CHANGED OVER TO THE STANDARD NAVISTAR SF CATHETER PLUS REBOOTING THE PIU, IT ELIMINATED ERROR 8 AND THE CASE WAS CONTINUED. THE STIMULATOR BEING USED DURING THIS CASE IS BIOTRONIK. THE EXTREME INTERFERENCE ON ALL THE BODY SURFACE AND INTRACARDIAC SIGNALS ON BOTH THE GE RECORDING SYSTEM AND THE CARTO 3 SYSTEM MARKED THE ALERT DATE OF THIS EVENT WHICH WAS (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1