BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3999263 · Received August 11, 2014

    Report

    Report Number
    3008203003-2014-00053
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING RE- PULMONARY VEIN ISOLATION (PVI) PROCEDURE, AS SOON AS A LASSO ECO NAV WAS CONNECTED TO THE PIU, THE GREEN PATCHES DISAPPEARED FROM THE LOCATION SETUP AND ERROR 41, 42, 43 WERE DISPLAYED. WHEN REBOOTING THE PIU FOR TROUBLESHOOTING, PIU WAS REBOOTING ITSELF IN A NEVER ENDING LOOP. THE PHYSICIAN ALSO STATED THAT THE SIGNALS TAKEN BY CS CATHETER WERE MEASURED IN A WRONG WAY ALSO ON THE LASSO CATHETER BIOSENSE FIELD SERVICE ENGINEERS COULD NOT BE DUPLICATED THE ISSUE ON SITE. NO ISSUES FOUND DURING SYSTEM CHECK. SUSPECTED BACKPLANE WAS REPLACED. FULL ACCEPTANCE TEST PROCEDURE (ATP) PERFORMED AFTER BACKPLANE REPLACEMENT. SYSTEM IS WORKING PROPERLY. BACKPLANE WAS SENT TO HTC FOR INVESTIGATION AND THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THE CARD WAS TESTED WITH A FEW TYPES OF CATHETERS(LASSO ECO NAV TESTED TOO) AT AQUARIUM STATION , PASSED POWER BIT TESTS AND SERVICE JIG UTILITY TESTS- REPORTED PROBLEM WAS NOT REPRODUCED. HOWEVER, DURING VISUAL INSPECTION, IT WAS FOUND BENT PINS IN MAP(J27) AND REF/DECA (J28) CONNECTORS, THE BENT PINS IN CONNECTOR J27 RELATES TO COMPLAINT AND COULD CAUSE TO REPORTED PROBLEM "WHEN THE ST CATHETER IS CONNECTED, CUSTOMER GETS ERRORS:41,42,43,44". A DHR REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RE- PULMONARY VEIN ISOLATION (PVI) PROCEDURE, AS SOON AS A LASSO ECO NAV WAS CONNECTED TO THE PIU, THE GREEN PATCHES DISAPPEARED FROM THE LOCATION SETUP AND ERROR 41, 42, 43 WERE DISPLAYED. WHEN REBOOTING THE PIU FOR TROUBLESHOOTING, PIU WAS REBOOTING ITSELF IN A NEVER ENDING LOOP. THE PHYSICIAN ALSO STATED THAT THE SIGNALS TAKEN BY CS CATHETER WERE MEASURED IN A WRONG WAY ALSO ON THE LASSO CATHETER. UPON FOLLOWING UP WITH THE CUSTOMER, BWI RECEIVED ADDITIONAL INFORMATION WHICH IS NOW INDICATIVE OF A REPORTABLE EVENT STATED THE CARTO PROCEDURE WAS CANCELLED AND THE CUSTOMER STOPPED USING THE SMART TOUCH CATHETER AND CARTO. THE CASE WAS COMPLETED WITH A NON NAV ABLATION CATHETER WITHOUT ANY PATIENT CONSEQUENCE WITH 1 HOUR DELAY. A TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO THE CASE DELAY. THE PHYSICIAN CONSIDERED THE PROCEDURE DELAY CAUSED A POTENTIAL RISK TO THIS PATIENT SINCE NO MAPPING OR USING OF THE CARTO NAVIGATION WERE POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476467 CARTO® 3 SYSTEM PROGRAMMABLE DIAGNOSTIC COMPUTER DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1