BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO XP EP NAVIGATION SYSTEM

    MDR report key: 1820298 · Received August 30, 2010

    Report

    Report Number
    9681484-2010-00017
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K042999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CONCOMITANT PRODUCT: EZ STEER THERMOCOOL SF NAV CATHETER, LOT # 15171347.THERE WERE NO ISSUES WITH THE CATHETER OR CARTO SYSTEM REPORTED BY THE CUSTOMER. DURING THE CASE THE TEMPERATURE DID NOT GET HIGHER THAN 34 DEGREES CELSIUS AND THE IRRIGATION WORKED AS EXPECTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED: PROCEDURE TYPE WAS LEFT VENTRICULAR TACHYCARDIA ABLATION. THE EVENT WAS POSSIBLY PROCEDURE RELATED. THE PATIENT WAS TAKEN TO A STROKE UNIT IN ANOTHER HOSPITAL FOR URGENT THROMBOLYSIS INTERVENTION. THE CARTO SYSTEM ASSOCIATED WITH THE REPORTED INCIDENT WAS THOROUGHLY INSPECTED BY BWI FIELD SERVICE ENGINEER. IT WAS REPORTED THAT NO ISSUE HAS BEEN ENCOUNTERED WITH EITHER THE CARTO SYSTEM. THE SYSTEM WAS WORKING AS EXPECTED. AFTER THAT PROBLEM OCCURRED, SEVERAL CASES WERE PERFORMED USING THE SAME UNIT. NO FURTHER PROBLEM HAS BEEN REPORTED. THE DEVICE HISTORY REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE OF THIS DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ABLATION PROCEDURE USING A EZ STEER THERMOCOOL SF NAV CATHETER THE PATIENT HAD A STROKE RESULTING IN HEMIPARESIS OF THE BODY AND INABILITY TO TALK. THE PATIENT WAS TRANSFERRED URGENTLY TO ANOTHER HOSPITAL TO UNDERGO SURGERY. ADDITIONAL INFORMATION RECEIVED: THE STROKE UNIT IN WHICH THE PATIENT WAS ADMITTED DISCOVERED THAT THE STROKE CONSISTED 99% OF CALCIFICATION THAT WAS IN THE AORTA. THE PATIENT HAS PARTIALLY RECOVERED AND CONTINUES TO GET BETTER; HOWEVER, THERE IS STILL SOME PERMANENT CEREBRAL DAMAGE. NO ADDITIONAL PATIENT INFORMATION COULD BE OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S