BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO¿ 3 SYSTEM

    MDR report key: 2250467 · Received September 15, 2011

    Report

    Report Number
    9681484-2011-00019
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM CUSTOMER (AFFILIATE): NO WARNING MESSAGE FROM CARTO. FLUORO POSITION THE SAME. WE DID A CARDIOVERSION ON PATIENT HOWEVER SYSTEM LOOKED LIKE IT COMPENSATED. NOT SURE HOW MANY MM WE HAD MOVEMENT. HOWEVER I CONFIRMED PLACEMENT WITH ULS BUT PHYSICIAN STILL INSISTED THERE WAS A MAP SHIFT. THIS WAS A CARTO 3 USED IN CONJUNCTION WITH ODYSSEY. RMT WAS NOT IN USE FOR THIS CASE. THE PHYSICIAN CREATED A MANUAL SHELL WITH THE LASSO CATHETER. ACL FUNCTION IN USE. PHYSICIAN EXPRESSED CONCERN OF MAP SHIFT RELATIVE TO CATHETER AND HIS POSITION ON FLUORO. CARDIOVERSION WAS PERFORMED AND THE SYSTEM DID NOT INDICATE A PATIENT AND OR PATCH MOVEMENT. THE MAPPING, LASSO AND CS CATHETERS WERE CONNECTED TO THE PIU. PER PHYSICIAN, THE ACL CATHETER SHIFTED, AND THEY DID NOT USE RMT CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CARTO MANUFACTURER RECEIVED A COPY OF THE DATA RELATED TO THE ISSUE, BUT COULDN'T INVESTIGATE IT BECAUSE 50% OF THE RECORDINGS WERE MISSING DUE TO SOME ACTION DONE WHEN THE DATA WAS COPIED. THERE WAS NO OPTION TO RETRIEVE THE ENTIRE RELATED DATA. THEREFORE, THE COMPLAINT ANALYSIS WAS CONCLUDED BASED ON THE AVAILABLE INFORMATION. THE REPORTED ISSUE IS RELATED TO (B)(4). HOWEVER, MAP SHIFT EVENT IS HIGHLY DETECTABLE AND PROBABILITY OF OCCURRENCE OF A SERIOUS INJURY AND/OR DEATH FROM MAP SHIFT IS VERY REMOTE. COMPLAINT CONDITION WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTO 3 RMT SUFFERED A MAP SHIFT DURING AN AFIB PROCEDURE. NAVIGANT WAS NOT IN USE FOR THIS CASE. THE SHIFT WAS IDENTIFIED BY FLUORO AND ULTRASOUND. THE PHYSICIAN BELIEVES THAT THE MAP SHIFT OCCURRED, BUT THE CLINICAL STAFF DID NOT. NO ERRORS WERE DISPLAYED ON THE CARTO. CASE RECORDINGS AND DEBUG FILES WILL BE COPIED FOR ANALYSIS. REFERRED TO FSE.

    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