BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5019675 · Received August 20, 2015

    Report

    Report Number
    3008203003-2015-00065
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) (CORONARY SINUS CATHETER CABLE) ARE RELATED TO THE SAME EVENT. (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND ELECTROCARDIOGRAMS DISAPPEARED FROM CARTO AND RECORDING SYSTEM. ADDITIONAL INFORMATION REFLECTS THAT THE ISSUE WAS RESOLVED BY CHANGING THE CS CABLE AND THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCES ON THE PATIENT ONLY THE PROCEDURE TOOK MORE TIME. THEREFORE, FOLLOW UP INVESTIGATION WAS MADE AND IT WAS INFORMED THAT INTRACARDIAC ELECTROCARDIOGRAMS WERE ALSO LOST. THERE WAS ALSO A 30 MINUTE DELAY EXPERIENCED BUT THE PHYSICIAN DID NOT CONSIDER THE DELAY A POTENTIAL RISK TO THE PATIENT, SO THE DELAY IS NOT AN INDICATIVE OF AN MDR REPORTABLE EVENT. THIS EVENT IS BEING REPORTED BECAUSE PHYSICIAN HAD NO ELECTROCARDIOGRAMS TO MONITOR PATIENT¿S HEART RHYTHM AND THE LACK OF MONITORING OF CARDIAC RHYTHM WHILE DEVICES ARE INTRACARDIAC MIGHT LEAD TO UNDETECTED RHYTHM THAT CAN BE LIFE THREATENING. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE ISSUE RESOLVED BY THE CUSTOMER CHANGING THE CORONARY SINUS CATHETER CABLE. THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCES ON THE PATIENT ONLY THE PROCEDURE TOOK MORE TIME. THIS COMPLAINT WAS RAISED FOR REPORTING PURPOSES ONLY AND NO FURTHER ACTION REQUIRED. SYSTEM IS OPERATIONAL. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE NO CAPA ACTIVITY IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND ELECTROCARDIOGRAMS DISAPPEARED FROM CARTO AND RECORDING SYSTEM. ADDITIONAL INFORMATION REFLECTS THAT THE ISSUE WAS RESOLVED BY CHANGING THE CS CABLE AND THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY CONSEQUENCES ON THE PATIENT ONLY THE PROCEDURE TOOK MORE TIME. THEREFORE, FOLLOW UP INVESTIGATION WAS MADE AND IT WAS INFORMED THAT INTRACARDIAC ELECTROCARDIOGRAMS WERE ALSO LOST. THERE WAS ALSO A 30 MINUTE DELAY EXPERIENCED BUT THE PHYSICIAN DID NOT CONSIDER THE DELAY A POTENTIAL RISK TO THE PATIENT, SO THE DELAY IS NOT AN INDICATIVE OF AN MDR REPORTABLE EVENT. THIS EVENT IS BEING REPORTED BECAUSE PHYSICIAN HAD NO ELECTROCARDIOGRAMS TO MONITOR PATIENT'S HEART RHYTHM AND THE LACK OF MONITORING OF CARDIAC RHYTHM WHILE DEVICES ARE INTRACARDIAC MIGHT LEAD TO UNDETECTED RHYTHM THAT CAN BE LIFE THREATENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551748 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1