BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO¿ XP SYSTEM

    MDR report key: 2902305 · Received January 8, 2013

    Report

    Report Number
    3008203003-2013-00006
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K042999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REF: (B)(4). DURING THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED A MAPSHIFT OCCURRED FOR A DIFFERENCE OF 2 CM. THE CARTO XP SYSTEM DID NOT DISPLAY AN ERROR MESSAGE. ADDITIONAL INFORMATION PROVIDED STATED THE MAPSHIFT WAS NOTICED BY COMPARING THE X-RAY IMAGE WITH THE CARTO XP IMAGE. MAPSHIFT DID NOT OCCUR DURING RF ABLATION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE CALIBRATION VALUES FOR THE LOCATION PAD WERE VERIFIED. THE CALIBRATION VALUES WERE ALL WITHIN SPECIFICATION. THE LOCATION PAD WAS FUNCTIONING PER SPECIFICATION. ADDITIONAL INFORMATION PROVIDED WAS STATING THE CUSTOMER DID NOT RECALL WHETHER THE FLUORO WAS MOVED WHEN THE ISSUE OCCURRED. DUE TO THE FACT THAT LOCATION PAD WAS FUNCTIONING WITHIN SPECIFICATION AND THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE REMAINS UNKNOWN, HOWEVER THE MAP SHIFT ISSUE MIGHT BE ATTRIBUTED TO A PATIENT MOVEMENT. THE PATIENT MOVEMENT COULD CAUSE A SHIFT IN THE HEART'S ANATOMICAL POSITION. DHR REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE. CUSTOMER'S COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED A MAPSHIFT OCCURRED FOR A DIFFERENCE OF 2 CM. THE CARTO XP SYSTEM DID NOT DISPLAY AN ERROR MESSAGE. ADDITOINAL INFORMATION PROVIDED STATED THE MAPSHIFT WAS NOTICED BY COMPARING THE X-RAY IMAGE WITH THE CARTO XP IMAGE. MAPSHIFT DID NOT OCCUR DURING RF ABLATION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9546 CARTO¿ XP SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4700-01

    Patients

    Seq Age Sex Outcome Treatment
    1