BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2861414 · Received December 7, 2012

    Report

    Report Number
    3008203003-2012-00073
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE THE CARTO 3 SYSTEM EXPERIENCED MAP SHIFT AFTER PATIENT MOVEMENT. THE LASSO CATHETER WAS IN THE PULMONARY VEINS AND WAS FOUND TO NOT CORRESPONDING TO THE DISPLAYED MAP LOCATION. THE SHIFT WAS NOTED NOT LINING UP WITH THE PULMONARY VEIN ON THE MERGED CT. PATIENT WAS UNDER CONSCIOUS SEDATION AND HAD MOVED EXCESSIVELY DURING THE PROCEDURE. NO CARDIOVERSION WAS PERFORMED PRIOR TO THE SHIFT. THE MAP SHIFT WAS APPROXIMATELY 10 MM. BOTH THE ACL CATHETER AND MAGNETIC CATHETERS SHIFTED IN THE SAME DIRECTION AND THE SAME AMOUNT OF SHIFT. A NEW MAP WAS CREATED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT'S INJURY. AFTER FURTHER EVALUATION IT WAS DETERMINED THE REASON WHY MAP SHIFT OCCURRED WITHOUT ANY ERROR MESSAGES COULD POTENTIAL BE DUE TO AN ACCUMULATIVE SERIES OF ALLOWED SYSTEM COMPENSATED PATIENT MOVEMENTS. NO MAP SHIFTS WERE NOTICED IN THE FOLLOWING PROCEDURES. DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE THE CARTO 3 SYSTEM EXPERIENCED A REMARKABLE MAP SHIFT AFTER PATIENT MOVEMENT. THE LASSO CATHETER WAS IN THE PULMONARY VEINS AND WAS FOUND TO NOT CORRESPONDING TO THE DISPLAYED MAP LOCATION. THE SHIFT WAS NOTED NOT LINING UP WITH THE PULMONARY VEIN ON THE MERGED CT. PATIENT WAS UNDER CONSCIOUS SEDATION AND HAD MOVED EXCESSIVELY DURING THE PROCEDURE. NO CARDIOVERSION WAS PERFORMED PRIOR TO THE SHIFT. THE MAP SHIFT WAS APPROXIMATELY 10 MM. BOTH THE ACL CATHETER AND MAGNETIC CATHETERS SHIFTED IN THE SAME DIRECTION AND THE SAME AMOUNT OF SHIFT. THE CASE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

    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