BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4963208 · Received August 4, 2015

    Report

    Report Number
    3008203003-2015-00060
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 14, 2015
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) THE CUSTOMER EXPERIENCED A MAP SHIFT BIGGER THAN 5 CM WITHOUT ANY ERROR DURING THE MAPPING PHASE. THE CUSTOMER CREATED NEW MAP AND THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. THE PATIENT WAS UNDER GENERAL ANESTHESIA WITHOUT ANY MOVEMENT. THE MAP SHIFT WITHOUT ERROR IS INDICATED OF REPORTABLE EVENT. BIOSENSE FIELD SERVICE ENGINEERS ADVISED CLINICAL ACCOUNT SPECIALIST TO USE A DEFAULT TEMPLATE DURING THE NEXT CASES. IT WAS STATED THAT THE ISSUE DID NOT OCCUR/COULD NOT BE DUPLICATED DURING LAST TWO CASES AND ALSO STATED THAT THE DEFAULT TEMPLATE WAS USED AS ADVISED. SYSTEM IS READY FOR USE. DHR REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT), THE CUSTOMER EXPERIENCED A MAP SHIFT BIGGER THAN 5 CM WITHOUT ANY ERROR DURING THE MAPPING PHASE. THE CUSTOMER CREATED NEW MAP AND THE CASE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. THE PATIENT WAS UNDER GENERAL ANESTHESIA WITHOUT ANY MOVEMENT. THE MAP SHIFT WITHOUT ERROR IS INDICATED OF REPORTABLE EVENT. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510482 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1