BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2834088 · Received November 15, 2012

    Report

    Report Number
    3008203003-2012-00055
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE WHEN THE CUSTOMER DREW THE CONTOURS WITH THE CARTO 3 SOUND AND THE CYPRESS ULTRASOUND MACHINE, THE ULTRASOUND CONTOURS WERE DISPLACED TO THE LEFT APPROXIMATELY 15-20 MM COMPARED TO THE FAM DATA. THE OFFSET DID NOT HAPPEN DURING ABLATION. NO CARDIOVERSION, FLUOROSCOPY HEAD BEING MOVED, LOOSE OF REFERENCE PATCH WERE FOUND PRIOR TO THE ISSUE. THE CASE WAS COMPLETED. NO PATIENT ADVERSE EVENT WAS REPORTED. THE BWI FIELD SERVICE ENGINEER REPORTED THAT IT WAS DISCOVERED THAT THE SETTING IN THE CARTO 3 SYSTEM WAS FOR CYPRESS PLUS INSTEAD OF STANDARD CYPRESS THAT IS BEING USED. THE BWI FIELD SERVICE ENGINEER ADVISED THE BWI FIELD REPRESENTATIVE HOW TO DELETE THE CYPRESS PLUS SETTING AND CREATE A NEW CYPRESS PRESET IN THE ULTRA SOUND MACHINE CONFIGURATIONS. NO FURTHER ISSUES TO REPORT AFTER THIS WAS COMPLETED. THE PROBLEM HAS BEEN RESOLVED. THE REPORTED ISSUE IS NOT A MAP SHIFT, BUT RATHER THE MISALIGNMENT OF TWO DIFFERENT MAPS (FAST ANATOMICAL MAPPING FAM AND THE ULTRA SOUND MAP). THE ULTRA SOUND MAP WAS NOT CORRECT BECAUSE OF THE WRONG TYPE OF ULTRA SOUND MACHINE WAS SELECTED BY THE USER. THE SYSTEM IS NOW OPERATIONAL. AN ADDITIONAL OEM MANUFACTURER ACTION DEVICE HISTORY RECORD (DHR) WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE WHEN THE CUSTOMER DREW THE CONTOURS WITH THE C3SOUND AND THE CYPRESS ULTRASOUND MACHINE, THE ULTRASOUND CONTOURS WERE DISPLACED TO THE LEFT APPROXIMATELY 15-20 MM COMPARED TO THE FAM DATA. THE OFFSET DID NOT HAPPEN DURING ABLATION. NO CARDIOVERSION, FLUOROSCOPY HEAD BEING MOVED, LOOSE OF REFERENCE PATCH WERE FOUND PRIOR TO THE ISSUE. THE CASE WAS COMPLETED. NO PATIENT ADVERSE EVENT 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