BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2963765 · Received February 15, 2013

    Report

    Report Number
    3008203003-2013-00021
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    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
    DA
    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 A PROCEDURE A MAP SHIFT OCCURRED. THERE WAS NO WARNING MESSAGE OBSERVED ON THE CARTO SYSTEM IN RELATION TO THE SHIFT. THE MAP SHIFT DID NOT HAPPEN DURING RF ABLATION. BOTH THE MAGNETIC CATHETER AND THE ACL CATHETER MOVED RELATIVE TO THE MAP, APPROXIMATELY 5-6 MM IN THE SAME DIRECTION. THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCE WAS REPORTED. THE LOG FILES AND RECORDINGS WERE SENT TO THE MANUFACTURER FOR INVESTIGATION. IT WAS NOTED THAT THERE WERE STRONG METAL VALUES ON THE CATHETER AND IN PART OF THE PATCHES. MANY TIMES THE CATHETER REACHED THE SUBOPTIMAL THRESHOLD OF 8. STEP WISE FROM THE CHANGE IN METAL PATCH VALUES IT APPEARED LIKE THERE WAS (B)(6)'S HIGH METAL VALUES, HOWEVER THE CATHETER VALUES WERE MUCH HIGHER. ON OTHER PARTS THE CATHETER METAL VALUE ROSE BY ITSELF. THIS ISSUE WAS RELATED TO THE SID POSTER AND PATIENT SETUP. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE OF THIS DEVICE. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE A MAP SHIFT OCCURRED. THERE WAS NO WARNING MESSAGE OBSERVED ON THE CARTO SYSTEM IN RELATION TO THE SHIFT. THE MAP SHIFT DID NOT HAPPEN DURING RF ABLATION. BOTH THE MAGNETIC CATHETER AND THE ACL CATHETER MOVED RELATIVE TO THE MAP, APPROXIMATELY 5-6 MM IN THE SAME DIRECTION. THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68717 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1