BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4936393 · Received July 23, 2015

    Report

    Report Number
    3008203003-2015-00057
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 8, 2015
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    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. PRODUCT NAME: PENTARAY NAV F CURVE US CATALOG #: UNKNOWN LOT #: UNKNOWN PRODUCT NAME: SMARTTOUCH DF CURVE US CATALOG #: UNKNOWN LOT #: UNKNOWN PRODUCT NAME: BW DECAPOLAR DF CURVE US CATALOG #: UNKNOWN LOT #: UNKNOWN (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM AND EXPERIENCED A MAP SHIFT WITHOUT SYSTEM DISPLAYING AN ERROR MESSAGE. THIS WAS NOTICED SINCE THE RIGHT SUPERIOR PULMONARY VEIN WAS NOT AT THE SAME PLACE AS ON THE BEGINNING OF THE PROCEDURE. PHYSICIAN USED FLUOROSCOPY TO CONFIRM CATHETER¿S POSITION. FURTHER INVESTIGATION WAS PERFORMED AND IT INFORMED THAT THE MAP SHIFT ISSUE WAS SEEN DURING MAPPING AND ABLATING, AS WELL AS THE MAP MOVEMENT WAS APPROXIMATELY FROM 5 TO 10 MILLIMETERS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT IS BEING REPORTED BECAUSE SUCH MAP SHIFTS COULD POTENTIALLY MISLEAD PHYSICIAN AND CONTRIBUTE IN A POTENTIAL RISK TO PATIENT. THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED. FSE CONFIRMED THAT NO SERVICE ACTIVITY WAS REQUIRED FOR THIS COMPLAINT. FSE CONTACTED REPS INVOLVED IN SUPPORTING THIS CUSTOMER, FOLLOWING UP THE ISSUE, AND WAS INFORMED THE NEXT TWO CASES REPORTED MAP SHIFT ISSUE WAS NOT REPEATED. SYSTEM IS OPERATIONAL. THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH CARTO 3 SYSTEM # (B)(4) WAS REVIEWED. THERE WAS NO ANY ADDITIONAL COMPLAINT OUT OF (B)(4) ADDITIONAL REPORTED COMPLAINTS THAT MAY BE RELATED TO THE REPORTED ISSUE. 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 A PULMONARY VEIN ISOLATION ABLATION PROCEDURE WITH A CARTO® SYSTEM AND EXPERIENCED A MAP SHIFT WITHOUT SYSTEM DISPLAYING AN ERROR MESSAGE. THIS WAS NOTICED SINCE THE RIGHT SUPERIOR PULMONARY VEIN WAS NOT AT THE SAME PLACE AS ON THE BEGINNING OF THE PROCEDURE. PHYSICIAN USED FLUOROSCOPY TO CONFIRM CATHETER'S POSITION. FURTHER INVESTIGATION WAS PERFORMED AND IT INFORMED THAT THE MAP SHIFT ISSUE WAS SEEN DURING MAPPING AND ABLATING, AS WELL AS THE MAP MOVEMENT WAS APPROXIMATELY FROM 5 TO 10 MILLIMETERS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT IS BEING REPORTED BECAUSE SUCH MAP SHIFTS COULD POTENTIALLY MISLEAD PHYSICIAN AND CONTRIBUTE IN A POTENTIAL RISK TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481204 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1