BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2810273 · Received October 31, 2012

    Report

    Report Number
    3008203003-2012-00047
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON THE DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. THE CONCOMITANT PRODUCT: SMART TOUCH BIDIRECTIONAL MODEL# D-1327-00-S, LOT # UNKNOWN (NOT FDA APPROVED). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, ALL ECG SIGNALS WERE FLAT LINED AND THAT IT APPEARED THAT ELECTRICAL SIGNAL CAME TO THE PATIENT. WHEN CATHETER WAS CONNECTED, THE ECG SIGNALS WENT FLAT. AFTER INVESTIGATION IT WAS DETERMINED THIS ISSUE WAS CAUSED BY AN INCORRECT USE OF CABLE. AN INCORRECT INTERFACE CABLE WITH MALE CONNECTOR (25 PIN) WAS USED TO CONNECT THE SMART TOUCH CATHETER WHICH ALSO HAS A MALE CONNECTOR (34 PIN). NO SOLID CONNECTION CAN BE MADE BETWEEN THESE TWO MALE CONNECTORS AND IT WOULD RESULT IN LOOSE CONNECTION. THESE TWO CONNECTORS ARE ALSO COLOR CODED DIFFERENTLY, ONE IS BLACK AND THE OTHER IS GRAY. A TESTING ENVIRONMENT WAS SET UP TO VERIFY THE ELECTRICAL SIGNAL ISSUE DESCRIBED IN THIS COMPLAINT. THE TESTING WAS PERFORMED BY FORCING A SMARTTOUCH CATHETER TO CONNECT TO THE INCORRECT CABLE (CABLE USED BY THE PHYSICIAN). THE CATHETER TIP WAS THEN SUBMERGED IN A WATER TANK AND SOME BUBBLES WERE OBSERVED AT SOME ANGULAR POSITION ON THE CATHETER'S TIP. THE BUBBLES WERE CAUSED BY SUPPLY VOLTAGE (10 VOLTS) SENT TO ONE OF THE PROXIMAL ELECTRODE DUE TO THE INCORRECT CONNECTION. IN CONCLUSION, IT WAS DETERMINED THE CUSTOMER FORCED THE SMARTTOUCH CATHETER INTO AN INCORRECT CABLE WHICH RESULTED IN THIS COMPLAINT. THIS COMPLAINT WAS CAUSED BY USER ERROR. THE IFU STATES THAT THE CATHETER SHOULD BE CONNECTED TO THE PATIENT INTERFACE UNIT (PIU) VIA THE APPROPRIATE BIOSENSE WEBSTER CABLE. THE ANALYSIS CONCLUSION WAS PROVIDED TO THE CLINICAL ACCOUNT SPECIALIST TO MAKE THE CUSTOMER AWARE OF THE IMPORTANCE OF USING THE CORRECT CABLE INDICATED IN THE IFU. THE DHR ASSOCIATED WITH CARTO 3 # 11830 WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, ALL ECG SIGNALS WERE FLAT LINED AND THAT IT APPEARED THAT ELECTRICAL SIGNAL CAME TO THE PATIENT. UPON FOLLOW UP, BWI RECEIVED THE INFORMATION ON (B)(6) 2012 (WHICH CHANGED THE ALERT DATE), THAT SHOWED WHEN THE PHYSICIAN CONNECTED THE INTERFACE CABLE TO THE SMART TOUCH CATHETER THE PATIENT WAS FEELING PAIN IN THE CHEST AND BY DISCONNECTING THE SMART TOUCH CATHETER THE PATIENT SAID THAT THE PAIN WAS GONE. THE PHYSICIAN ASSUMED THAT THERE WAS A LEAK-CURRENT FROM SMART TOUCH CATHETER TO THE PATIENT; THEREFORE, THE PHYSICIAN STOPPED THE CARTO PROCEDURE AND FINISHED THE PROCEDURE WITHOUT THE CARTO. AFTER CHECKING THE USED PRODUCTS THEY FOUND THAT THEY USED THE WRONG INTERFACE CABLE.

    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