BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3010429 · Received March 19, 2013

    Report

    Report Number
    3008203003-2013-00035
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING AN AF ABLATION PROCEDURE IT WAS REPORTED THERE WERE NOISE ON THE ECG TRACKS ON BOTH CARTO 3 AND EP RECORDING SYSTEMS. ADDITIONAL INFORMATION PROVIDED STATED THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS. THE NOISE OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS NOT ABLE TO INTERPRET EITHER BS OR THE IC RECORDINGS DUE TO THE PRESENCE OF NOISE. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE PROCEDURE DUE TO THE NOISE ISSUE. THERE WAS NO PATIENT¿S CONSEQUENCE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED. THE PATIENT WAS UNDER LOCAL ANESTHESIA. THE PROCEDURE WAS PERFORMED IN THE LEFT ATRIUM. TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE CASE CANCELLATION. THE PHYSICIAN DID NOT CONSIDER CANCELLING THE PROCEDURE WOULD CAUSE A POTENTIAL RISK TO THE PATIENT. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION DUE TO PROCEDURE CANCELLATION. THE FAULTY CARTO 3 WORK STATION WAS REPLACED WITH ANOTHER UNIT. THE FAULTY WORKSTATION WAS SENT FOR REPAIR. AFTER UNIT EVALUATION IT WAS DETERMINED THE REPORTED ISSUES WERE UNABLE TO BE DUPLICATED. THE UNIT DID NOT ENCOUNTER SIMILAR ISSUES IN THE FOLLOWING CASES. DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING AN AF ABLATION PROCEDURE IT WAS REPORTED THERE WERE NOISE ON THE ECG TRACKS ON BOTH CARTO 3 AND EP RECORDING SYSTEMS. ADDITIONAL INFORMATION PROVIDED STATED THE SIGNAL NOISE OCCURRED ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BS AND ALL IC (INTRACARDIAL) RECORDINGS. THE NOISE OCCURRED ON BOTH CARTO AND THE RECORDING SYSTEM AT THE SAME TIME. THE PHYSICIAN WAS NOT ABLE TO INTERPRET EITHER BS OR THE IC RECORDINGS DUE TO THE PRESENCE OF NOISE. THE PHYSICIAN WAS NOT ABLE TO COMPLETE THE PROCEDURE DUE TO THE NOISE ISSUE. THERE WAS NO PATIENT'S CONSEQUENCE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED. THE PATIENT WAS UNDER LOCAL ANESTHESIA. THE PROCEDURE WAS PERFORMED IN THE LEFT ATRIUM. TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE CASE CANCELATION. THE PHYSICIAN DID NOT CONSIDER CANCELING THE PROCEDURE WOULD CAUSE A POTENTIAL RISK TO THE PATIENT. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION DUE TO PROCEDURE CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114081 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1