BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2962146 · Received February 14, 2013

    Report

    Report Number
    3008203003-2013-00019
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED DURING AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/(WPW) PROCEDURE, THE CARTO 3 SYSTEM HAD NOISY ECG SIGNALS ACROSS ALL CHANNELS. ERROR 8 "PACE ROUTING DISABLED" WAS ALSO REPORTED. THE BWI FIELD REPRESENTATIVE STATES THAT PORT QUAD B HAD PINS BROKEN OFF IN IT FROM A YELLOW PIN BOX. IT WAS RECOMMENDED TO REMOVE ALL CATHETERS AND REBOOT THE PATIENT INTERFACE UNIT (PIU). THE PROCEDURE WAS CONTINUED CONVENTIONALLY. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE NOISE OCCURRED ON ALL BODY SURFACE (BS) ECGS AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 AND EP RECORDING SYSTEMS. IT WAS A REPEATING RINGING NOISE THROUGH ALL SIGNALS FOLLOWED BY THE LOSS OF THE BODY SURFACE (BS) ECGS. THE PHYSICIAN WAS NOT WITH ANY CONSISTENCY ABLE TO INTERPRET THE SIGNALS WITH THE PRESENCE OF THE NOISE. THE NOISE OCCURRED WHEN THE RF CABLE WAS CONNECTED TO THE STOCKERT GENERATOR. IT WAS PLANNED PACING FOR ARRHYTHMIA INDUCTION. THE PACING ABILITY WAS NOT LOST ON THE CARDIOLAB SYSTEM EVEN WITH THE CARTO 3 SYSTEM ERROR 8 "STIMULATION DISABLED." THE BACKPLANE BOARD WAS REPLACED. THE SYSTEM PASSED ALL TESTS AND IS READY FOR USE. THE FAULTY BACKPLANE WAS SENT TO (B)(6) FOR INVESTIGATION, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE CONNECTOR J29 (QUAD A) WAS FOUND DAMAGED. THERE WAS BROKEN AND BENT PINS FOUND IN THE CONNECTOR QUAD A THAT CAUSED TO REPORTED PROBLEM. THE CARD WAS SENT TO THE SUBCONTRACTOR FOR REPAIR AND UPGRADE. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/(WPW) PROCEDURE, THE CARTO 3 SYSTEM HAD NOISY ECG SIGNALS ACROSS ALL CHANNELS. ERROR 8 "PACE ROUTING DISABLED" WAS ALSO REPORTED. THE BWI FIELD REPRESENTATIVE STATES THAT PORT QUAD B HAD PINS BROKEN OFF IN IT FROM A YELLOW PIN BOX. IT WAS RECOMMENDED TO REMOVE ALL CATHETERS AND REBOOT THE PATIENT INTERFACE UNIT (PIU). THE PHYSICIAN DECLINED TROUBLESHOOTING AT THE TIME OF THE CALL. THE PROCEDURE WAS CONTINUED CONVENTIONALLY. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE NOISE OCCURRED ON ALL BODY SURFACE (BS) ECG'S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 AND EP RECORDING SYSTEMS. IT WAS A REPEATING RINGING NOISE THROUGH ALL SIGNALS FOLLOWED BY THE LOSS OF THE BODY SURFACE (BS) ECG'S. THE PHYSICIAN WAS NOT WITH ANY CONSISTENCY ABLE TO INTERPRET THE SIGNALS WITH THE PRESENCE OF THE NOISE. THE NOISE OCCURRED WHEN THE RF CABLE WAS CONNECTED TO THE STOCKERT GENERATOR. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY BYPASSING THE CARTO 3 SYSTEM. IT WAS PLANNED PACING FOR ARRHYTHMIA INDUCTION. THE PACING ABILITY WAS NOT LOST ON THE CARDIOLAB SYSTEM EVEN WITH THE CARTO 3 SYSTEM ERROR 8 "STIMULATION DISABLED." THE USER WAS NOT TRYING TO PACE AND ABLATE FROM THE SAME CATHETER SIMULTANEOUSLY. THE BLOOM STIMULATOR WAS BEING USED. THE PHYSICIAN DID NOT THINK THERE WAS ANY POTENTIAL RISK TO THE PATIENT FROM THIS PACING ISSUE. THE REPEATING RINGING NOISE ON ALL THE BODY SURFACE (BS) ECG'S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO 3 AND EP RECORDING SYSTEM IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66148 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1