BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 6198284 · Received December 22, 2016

    Report

    Report Number
    3008203003-2016-00047
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 24, 2016
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ¿SUSPECTED MEDICAL DEVICE¿ OF "CARTO 3 SYSTEM VERSION 6" REPORTED IN THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO CARTO 3 SYSTEM APPROVED UNDER K133916. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. DURING MAPPING, THERE WERE TWO MAP SHIFTS OF AT LEAST 1 CM WITH NO ERROR MESSAGES. THERE WAS ALSO NO CARDIOVERSION PERFORMED AND NO PATIENT MOVEMENT PRIOR TO THESE MAP SHIFTS. REMAPPING WAS PERFORMED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. ISSUE WAS INVESTIGATED BY THE DEVICE MANUFACTURER AND IT WAS FOUND THAT AFTER A SHORT TIME SINCE THE STUDY WAS STARTED THERE WAS MOVEMENT OF THE UPPER PART OF THE PATIENT TORSO WHICH IS NOT RECOGNIZED BY THE BACK PATCH. IT RESULTED WITH A ~13 MM SHIFT OF THE CHEST PATCH AVERAGE POSITION WHILE THE BACK PATCH DID NOT MOVE. MAP SHIFT ISSUE IS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU) WHEN THERE IS NOT ANY MOVEMENT OF THE BACK PATCHES HOWEVER THE PATIENT MOVED IN SUCH A WAY AS TO CAUSE A SHIFT IN THE HEART'S ANATOMICAL POSITION. ISSUE WAS NOT DUPLICATED NEXT CASES. THE DEVICE HISTORY RECORD (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 AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. DURING MAPPING, THERE WERE TWO MAP SHIFTS OF AT LEAST 1 CM WITH NO ERROR MESSAGES. THERE WAS ALSO NO CARDIOVERSION PERFORMED AND NO PATIENT MOVEMENT PRIOR TO THESE MAP SHIFTS. REMAPPING WAS PERFORMED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THIS ISSUE HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION AS SUCH MAP SHIFTS WITHOUT AN ERROR MESSAGE COULD POTENTIALLY BE CAUSED BY A SYSTEM MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849613 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1