BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3

    MDR report key: 6898666 · Received September 27, 2017

    Report

    Report Number
    3008203003-2017-01007
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    August 31, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR LEFT ATRIAL FLUTTER WITH A CARTO 3 SYSTEM WHERE A MAP SHIFT OCCURRED AT THE END OF THE PROCEDURE. NO ERROR MESSAGES POPULATED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. PRODUCT INVESTIGATION SUMMARY: THE BIOSENSE WEBSTER INC. FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT A REBOOT RESOLVED THE MAP SHIFT ISSUE. IT WAS DETERMINED THAT THE PATIENT MOVED SLIGHTLY BETWEEN REMAPS. THE REBOOT RESET THE BCS TO 0 POSITION. NO FURTHER ISSUES WERE WITNESSED. CUSTOMER DID NOT WANT THE SYSTEM TESTED. SYSTEM IS OPERATIONAL AND IS READY FOR USE. DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WHICH ARE RELATED TO THE REPORTED ISSUE WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT PRODUCTS: THERMOCOOL SMART TOUCH BIDIRECTIONAL SF CATHETER, MODEL # D-1348-05-S, LOT # 17689372L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR LEFT ATRIAL FLUTTER WITH A CARTO 3 SYSTEM WHERE A MAP SHIFT OCCURRED. AT THE END OF THE PROCEDURE, A MAP SHIFT OCCURRED. NO ERROR MESSAGES POPULATED. NO TROUBLESHOOTING WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, BUT NONE WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677774 CARTO 3 COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1