BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4100409 · Received September 19, 2014

    Report

    Report Number
    3008203003-2014-00061
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 19, 2014
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A CARTO 3 SYSTEM AND A MAP SHIFT ¿ NO ERROR MESSAGE ISSUE OCCURRED. THERE WAS A MAP SHIFT ON RAO VIEW DURING THE PROCEDURE. THE ISSUE WAS RESOLVED BY MOVING THE FLUORO TUBE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE SHIFT WAS NOTICED DURING THE MAPPING PORTION OF THE PROCEDURE. THE ISSUE OCCURRED WITH THE MOVEMENT OF THE FLUORO TUBE. A STABLE LAO HIS POSITION WAS CONFIRMED AND WHEN THE TUBE WAS ROTATED TO RAO, THE CATHETER SHIFTED. LAO POSITION CORRECTED THE SHIFT. THE SID VALUES FOR THIS PARTICULAR FLUORO SYSTEM ARE VERY STRICT. THE SHIFT WAS NOTICEABLE AT ABOUT 2CM. THERE WERE NO ERRORS ASSOCIATED WITH THE CATHETER SHIFT. THERE WAS NO SHIFT DURING RF DELIVERY. THEY RECOGNIZED THE SHIFT AND POSITIONED THE FLUORO ACCORDINGLY. THE REPORTED ISSUE WAS RELATED TO THE USER ERROR AND WAS RESOLVED BY FLUORO TUBE REPOSITIONING. THE BWI FIELD SERVICE ENGINEER COMPLETED ALL SYSTEM ACCEPTANCE TESTS. THE SYSTEM IS READY FOR USE. ACCORDING TO CARTO 3 INSTRUCTIONS FOR USE, FLUOROSCOPY DEVICES THAT ARE TOO CLOSE TO THE PATIENT MIGHT AFFECT LOCATION ACCURACY AND, AS A RESULT, CATHETER VISUALIZATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A CARTO 3 SYSTEM AND A MAP SHIFT ¿ NO ERROR MESSAGE ISSUE OCCURRED. THERE WAS A MAP SHIFT ON RAO VIEW DURING THE PROCEDURE. THE ISSUE WAS RESOLVED BY MOVING THE FLUORO TUBE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT ON (B)(4) 2014. THE SHIFT WAS NOTICED DURING THE MAPPING PORTION OF THE PROCEDURE. THE ISSUE OCCURRED WITH THE MOVEMENT OF THE FLUORO TUBE. A STABLE LAO HIS POSITION WAS CONFIRMED AND WHEN THE TUBE WAS ROTATED TO RAO, THE CATHETER SHIFTED. LAO POSITION CORRECTED THE SHIFT. THE SID VALUES FOR THIS PARTICULAR FLUORO SYSTEM ARE VERY STRICT. THE SHIFT WAS NOTICEABLE AT ABOUT 2CM. THERE WERE NO ERRORS ASSOCIATED WITH THE CATHETER SHIFT. THERE WAS NO SHIFT DURING RF DELIVERY. WE RECOGNIZED THE SHIFT AND POSITIONED THE FLUORO ACCORDINGLY. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF NO ERROR MESSAGE WITH THIS TYPE OF MAP SHIFT ON (B)(4) 2014 AND HAVE REASSESSED THE EVENT AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585072 CARTO® 3 SYSTEM PROGRAMMABLE DIAGNOSTIC COMPUTER DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1