BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2842866 · Received November 21, 2012

    Report

    Report Number
    3008203003-2012-00068
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCT: SMART TOUCH BIDIRECTIONAL: MODEL #: D-1327-05-S, LOT #15657570M. SMART TOUCH BIDIRECTIONAL CATHETER WAS ALSO REPORTED AS HAVING A VERY BAD CHAR. THIS CATHETER HAS NOT BEEN APPROVED BY US FDA AND IS NOT MARKETED IN THE US THEREFORE, THIS COMPLAINT IS NOT MDR REPORTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING THE END OF A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WAS A MAP SHIFT OF 2.5 TO 3 CM. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURIES. IT WAS NOTICED THAT AN OLD X-RAY SYSTEM WAS USED AND IT GETS CLOSER TO THE PATIENT'S BODY DURING EACH PROCEDURE. BIG AMOUNT OF METAL CAUSES MAGNETIC DISTORTION AND THEREFORE A MAP SHIFT WOULD BE OBSERVED. THEREFORE, THE CUSTOMER WAS ADVISED TO TAKE CARE OF THE RECOMMENDED SID VALUES IN ORDER TO AVOID MAP SHIFTS. A DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE END OF A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE, THERE WAS A MAP SHIFT OF 2.5 TO 3 CM. THERE WERE NO ERROR MESSAGES SEEN ON THE CARTO 3 SYSTEM. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND NO MOVEMENT WAS SEEN NOR CARDIOVERSION PERFORMED. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURIES. THE SMART TOUCH CATHETER WAS USED WITH A LASSO NON NAVIGATIONAL CATHETER. THE SHIFT WAS NOTICED ON BOTH THE CATHETERS IN THE VERTICAL DIRECTION. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE MAP SHIFT WAS RECOGNIZED AFTER THE ABLATION WAS DONE. IF IT STARTED WHILE ABLATION WAS ON, IT IS NOT KNOWN. THE MAP SHIFT DID NOT OCCUR AFTER THE USER MOVED THE HEAD OF FLUOROSCOPY. THE ACL FUNCTION WAS IN USE DURING THE PROCEDURE. ALL CATHETERS SHIFTED, BUT THE SHIFT WAS CLEARLY RECOGNIZED IN THE LASSO NON NAVIGATIONAL CATHETER. ALL THE CATHETERS MOVED IN THE SAME DIRECTION AND THE SAME AMOUNT OF SHIFT. THE REFERENCE PATCH DID NOT MOVE OR GET LOOSE BEFORE THE MAP SHIFT. AS IT WAS THE END OF THE CASE AND THE PHYSICIAN JUST WANTED TO CHECK THE VEINS, HE GUIDED THE LASSO NON NAVIGATIONAL CATHETER VIA FLUOROSCOPY INTO THE VEINS. NO REPLACEMENT WAS DONE. THE CATHETERS WERE CONNECTED TO 20 A - LASSO NON NAVIGATIONAL CATHETER, 20 B - SENSITHERM AND REF/DECA -CORONARY SINUS CATHETER. THE MAP SHIFT IS INDICATIVE OF A REPORTABLE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1