BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2840942 · Received November 20, 2012

    Report

    Report Number
    3008203003-2012-00061
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 1, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4). IT WAS REPORTED WHEN THE PHYSICIAN COMES OFF OF RF DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE LOCATION OF THE LASSO CATHETER CHANGES WITHOUT THE PHYSICIAN MOVING IT. IT IS A FIXED 10 POLE LASSO CATHETER. VISUALIZATION WAS RESET AND A NEW MATRIX WAS CREATED. THE LASSO CATHETER LOCATION STABILIZED SLIGHTLY, BUT STILL OCCURRED. THIS WAS NOT A MAP SHIFT BUT A SHIFT IN THE ACL DISPLAY OF THE LASSO CATHETER WHEN RF WAS INITIATED. THE ACL FUNCTION WAS IN USE/'TURNED ON' DURING THE CASE. THE LASSO CATHETER (NON NAV 20MM) WOULD SHIFT FROM ONE SIDE OF THE CATHETER TO THE OTHER (POLE 5 TO POLE 10). THE NAVISTAR CATHETER REMAINED IN ITS ORIGINAL LOCATION. THE PHYSICIAN DID NOT PERFORM A CARDIOVERSION PRIOR TO THIS SHIFT. THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. THE REFERENCE PATCH DID NOT MOVE OR GET LOOSE BEFORE THE SHIFT. CATHETER VISUALIZATION WAS RESET AND MATRIX REBUILT WHICH SEEMED TO HELP, BUT DID NOT TOTALLY RESOLVE THE ISSUE. THE PHYSICIAN WAS CONCERNED BECAUSE HE TARGETS THE LASSO CATHETER ELECTRODES FOR HIS PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. THE BWI FIELD SERVICE ENGINEER ARRIVED AT THE HOSPITAL AND PERFORMED FULL FUNCTIONAL TESTS. THE BWI FIELD SERVICE ENGINEER DID NOT FIND ANY ISSUES WITH THE SYSTEM. THE SYSTEM PASSED FULL FUNCTIONAL TESTS INCLUDING MAGNETIC AND ACL PORTIONS WITH NO PROBLEMS. THE SYSTEM WAS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED. HOWEVER, ACCORDING TO CARTO 3 INSTRUCTIONS FOR USE, IN RARE CASES WHEN THE RELATIVE POSITION BETWEEN THE PATCHES REMAINS THE SAME BUT THE POSITION OF THE HEART RELATIVE TO THE BACK PATCHES HAS CHANGED (FOR EXAMPLE, AFTER REPOSITIONING THE PATIENT'S HEAD ON A PILLOW OR MOVING THE PATIENT'S ARM WITHOUT CHANGING THE PATIENT'S POSITION ON THE MATTRESS, OR AFTER THE PATIENT IS CARDIOVERTED), THE SYSTEM WILL NOT GIVE A WARNING AND AN INCORRECT MAP (MAP SHIFT) MIGHT BE GENERATED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PHYSICIAN COMES OFF OF RF DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE LOCATION OF THE LASSO CATHETER CHANGES WITHOUT THE PHYSICIAN MOVING IT. IT IS A FIXED 10 POLE LASSO CATHETER. VISUALIZATION WAS RESET AND A NEW MATRIX WAS CREATED. THE LASSO CATHETER LOCATION STABILIZED SLIGHTLY, BUT STILL OCCURRED. THE PHYSICIAN WAS CONCERNED BECAUSE HE TARGETS THE LASSO CATHETER ELECTRODES FOR HIS PROCEDURE AND IS REQUESTING ON SITE FSE CASE SUPPORT. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE ON THE EVENT. THIS WAS NOT A MAP SHIFT BUT A SHIFT IN THE ACL DISPLAY OF THE LASSO CATHETER WHEN RF WAS INITIATED. THE ACL FUNCTION WAS IN USE/'TURNED ON' DURING THE CASE. THE LASSO CATHETER (NON NAV 20MM) WOULD SHIFT FROM ONE SIDE OF THE CATHETER TO THE OTHER (POLE 5 TO POLE 10). THE NAVISTAR CATHETER REMAINED IN IT'S ORIGINAL LOCATION. THE PHYSICIAN DID NOT PERFORM A CARDIOVERSION PRIOR TO THIS SHIFT. THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. THE REFERENCE PATCH DID NOT MOVE OR GET LOOSE BEFORE THE SHIFT. CATHETER VISUALIZATION WAS RESET AND MATRIX REBUILT WHICH SEEMED TO HELP, BUT DID NOT TOTALLY RESOLVE THE ISSUE.

    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