BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3088431 · Received May 1, 2013

    Report

    Report Number
    3008203003-2013-00057
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 17, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4). IT WAS REPORTED THAT DURING ABLATION PROCEDURE, THE NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS ECGS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND EP RECORDING SYSTEMS. CHANGING THE CABLES OF INDIFFERENT ELECTRODES, BS ECG, DC, REFERENCE PATCHES AND RF CABLES DID NOT SOLVE THE ISSUE. BY REPLACING ANOTHER SET OF 12 LEADS, THE ISSUE WAS RESOLVED. ALSO THE SEVERE SIGNAL NOISE OCCURRED AT THE BIPOLAR ELECTRODE 3-4 OF A NAVISTAR CATHETER. CHANGING THE NAVISTAR CATHETER, THE CABLE CONNECTED TO THE NAVISTAR CATHETER AND IC-OUT CABLE DID NOT SOLVE THE ISSUE. THE ISSUE WAS TENTATIVELY RESOLVED BY REBOOTING CARTO. THE NOISE ISSUE RECURRED WHEN THE PHYSICIAN SELECTED "CONTINUED STUDY" AND SELECTED A CS CATHETER TO ATTACH 20POLE B IN THE "CATHETER SETUP." EVENTUALLY, THE CS CATHETER WAS ATTACHED TO LAB, NOT CARTO DIRECTLY. IN ADDITION, THE PHYSICIAN FELT THE ANATOMY WAS HARD TO SEE WHEN MAPPING WAS STARTED WITH THE SOUNDSTAR CATHETER FROM RIGHT ATRIUM SIDE. THE SOUNDSTAR WAS ROTATED AND THE PHYSICIAN FOUND THE VIEW OF THE IMAGE WAS UPSIDE DOWN. THE FAN SHOWED RIGHT VENTRICULAR EVEN THOUGH THE CATHETER WAS ROTATED TO COUNTERCLOCKWISE AND SO THE FAN SHOULD HAVE SHOWN LEFT VENTRICULAR. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER. FIELD SERVICE ENGINEERING REPORTED THAT THE PROBLEM DID NOT OCCUR AT THE TIME OF A VISIT. FULL SYSTEM TESTS PERFORMED AND COMPLETED. SYSTEM IS WORKING FINE. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: EZ STEER THERMOCOOL SF NAV: MODEL # D-1317-05-S, LOT # 15797544L. SOUNDSTAR: MODEL# M-5723-12, LOT # UNKNOWN. MANUFACTURER REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS ECGS AND ALL IC (INTRACARDIAL) RECORDINGS ON BOTH CARTO AND EP RECORDING SYSTEMS. CHANGING THE CABLES OF INDIFFERENT ELECTRODES, BS ECG, DC, REFERENCE PATCHES AND RF CABLES DID NOT SOLVE THE ISSUE. BY REPLACING ANOTHER SET OF 12 LEADS, THE ISSUE WAS RESOLVED. ALSO THE SEVERE SIGNAL NOISE OCCURRED AT THE BIPOLAR ELECTRODE 3-4 OF A NAVISTAR CATHETER. CHANGING THE NAVISTAR CATHETER, THE CABLE CONNECTED TO THE NAVISTAR CATHETER AND IC-OUT CABLE DID NOT SOLVE THE ISSUE. THE ISSUE WAS TENTATIVELY RESOLVED BY REBOOTING CARTO. THE NOISE ISSUE RECURRED WHEN THE PHYSICIAN SELECTED "CONTINUED STUDY" AND SELECTED A CS CATHETER TO ATTACH 20POLE B IN THE "CATHETER SETUP". EVENTUALLY, THE CS CATHETER WAS ATTACHED TO LAB, NOT CARTO DIRECTLY. IN ADDITION, THE PHYSICIAN FELT THE ANATOMY WAS HARD TO SEE WHEN MAPPING WAS STARTED WITH THE SOUNDSTAR CATHETER FROM RIGHT ATRIUM SIDE. THE SOUNDSTAR WAS ROTATED AND THE PHYSICIAN FOUND THE VIEW OF THE IMAGE WAS UPSIDE DOWN. THE FAN SHOWED RIGHT VENTRICULAR EVEN THOUGH THE CATHETER WAS ROTATED TO COUNTERCLOCKWISE AND SO THE FAN SHOULD HAVE SHOWN LEFT VENTRICULAR. THE ISSUE WAS RESOLVED BY EXCHANGING THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189740 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) FG-5400-00M

    Patients

    Seq Age Sex Outcome Treatment
    1