BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3853208 · Received June 6, 2014

    Report

    Report Number
    3008203003-2014-00040
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THERE WAS A MAPSHIFT HOWEVER, THERE WERE NO ERROR MESSAGES PRESENT. THIS WAS INDICATIVE OF A REPORTABLE MALFUNCTION EVENT. PER THE DATA ANALYZED, THERE WERE WARNINGS MESSAGES FOR THIS ISSUE, THEREFORE THIS EVENT WOULD NOT BE INDICATIVE OF A REPORTABLE MALFUNCTION. MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA RIGHT (R-AT) PROCEDURE WITH A CARTO 3 SYSTEM, AND A MAP SHIFT - NO ERROR MESSAGE DEVICE MALFUNCTION OCCURRED. THE MAP SHIFT OCCURRED MIDWAY THROUGH THE PROCEDURE. THE PHYSICIAN PUT THE ABLATION CATHETER INTO THE INFERIOR VENA CAVA (IVC) AND PERFORMED SOME PACING MANEUVERS. HE THEN STARTED MAPPING AGAIN. IT WAS THEN NOTICED THAT THE MAP NO LONGER LINED UP. IT WAS A 10MM MAP SHIFT, POSTERIOR AND SUPERIOR. THERE WERE NO ERRORS PRESENT. THE HEAD OF FLUOROSCOPY WAS BEING MOVED THROUGHOUT THE PROCEDURE. HOWEVER, IT IS NOT KNOWN IF THE HEAD OF FLUOROSCOPY WAS MOVED AT THAT MOMENT. THE ACL CATHETER SHIFTED POSTERIOR AND SUPERIOR. ALSO, THE MAPPING CATHETER WAS BEING MOVED AROUND THE CHAMBER WHEN THE MAP SHIFT WAS NOTICED. THE DECA POLAR CATHETER WAS PLACED IN THE CORONARY SINUS AND PINNED INTO THE 20A PORT. THERE WAS NO CARDIOVERSION AND ALSO NO PATIENT MOVEMENT NOTICED. THE REFERENCE PATCH DID NOT MOVE OR GET LOOSE BEFORE THE MAP SHIFT. THE ACL FUNCTION WAS TURNED ON DURING THE PROCEDURE. A NEW MAP WAS CREATED AND THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION. THERE WAS NO PATIENT CONSEQUENCE. THE DATA RELATED TO THE ISSUE WAS SENT TO THE DEVICE MANUFACTURER AND WAS ANALYZED BY THE RESPONSIBLE ENGINEER. IT WAS DETERMINED THAT THE ISSUE WAS CAUSED BY FLUORO EFFECT/ OTHER METAL OBJECTS NEAR TO BACK PATCHES. DURING THE PROCEDURE, MULTIPLE METAL-DISTORTION WARNINGS WERE PRESENTED TO THE USER, AND TROUBLESHOOTING HAD BEEN PROPOSED BY ERROR MESSAGING. THE SYSTEM IS FULLY OPERATIONAL AND WORKS WITHIN SPECIFICATION. THE BWI FIELD SERVICE ENGINEER WILL EXPLAIN PROPER WORKFLOW TO THE BWI FIELD SERVICE REPRESENTATIVE AND GO OVER SID LIMITATIONS. NO FURTHER SERVICE NEEDED. SYSTEM IS READY FOR USE. A DEVICE HISTORY REVIEW (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 A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA RIGHT (R-AT) PROCEDURE WITH A CARTO 3 SYSTEM, AND A MAP SHIFT - NO ERROR MESSAGE DEVICE MALFUNCTION OCCURRED. THE MAP SHIFT OCCURRED MIDWAY THROUGH THE PROCEDURE. THE PHYSICIAN PUT THE ABLATION CATHETER INTO THE INFERIOR VENA CAVA (IVC) AND PERFORMED SOME PACING MANEUVERS. HE THEN STARTED MAPPING AGAIN. IT WAS THEN NOTICED THAT THE MAP NO LONGER LINED UP. IT WAS A 10MM MAP SHIFT, POSTERIOR AND SUPERIOR. THERE WERE NO ERRORS PRESENT. THE HEAD OF FLUOROSCOPY WAS BEING MOVED THROUGHOUT THE PROCEDURE. HOWEVER, IT IS NOT KNOWN IF THE HEAD OF FLUOROSCOPY WAS MOVED AT THAT MOMENT. THE ACL CATHETER SHIFTED POSTERIOR AND SUPERIOR. ALSO, THE MAPPING CATHETER WAS BEING MOVED AROUND THE CHAMBER WHEN THE MAP SHIFT WAS NOTICED. THE DECA POLAR CATHETER WAS PLACED IN THE CORONARY SINUS AND PINNED INTO THE 20A PORT. THERE WAS NO CARDIOVERSION AND ALSO NO PATIENT MOVEMENT NOTICED. THE REFERENCE PATCH DID NOT MOVE OR GET LOOSE BEFORE THE MAP SHIFT. THE ACL FUNCTION WAS TURNED ON DURING THE PROCEDURE. A NEW MAP WAS CREATED AND THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION. THERE WAS NO PATIENT CONSEQUENCE. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE BECAUSE DEVICE MALFUNCTION OF THIS TYPE COULD POTENTIALLY CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332069 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1