BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 12016863 · Received June 17, 2021

    Report

    Report Number
    2029046-2021-00946
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. THERE WAS NO ERROR GIVEN BY THE CARTO® 3 SYSTEM , THE SHIFT WAS A VISIBLE. THE ISSUE SEEN DURING ABLATION. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS 8 MM. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT AND THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT. DEVICE EVALUATION DETAILS: THE REPORTED ISSUE HAS BEEN INVESTIGATED. IT WAS FOUND THAT THE RESPIRATION GRAPH IS AFFECTED BY ABLATION, IT IS RESULTING FROM THE PATCH AMPLIFIER SATURATION, A NORMAL SYSTEM BEHAVIOR. PER THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THERE WAS NO MAP SHIFT BUT CATHETERS WERE MOVING ON ABLATION START AND STOP. THE BWI FIELD SERVICE ENGINEER FOLLOWED UP WITH THE BWI REPRESENTATIVE AND CONFIRMED THAT NO SERVICE FOR THE CARTO® 3 SYSTEM WAS BEING REQUESTED AT THIS TIME. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM (B)(6) WAS REVIEWED. NO SIMILAR COMPLAINTS WERE FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE SYSTEM (B)(6), AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A CARTO® 3 SYSTEM AND A MAP SHIFT ISSUE OCCURRED. THE CARTO® 3 SYSTEM SHIFTED AS SOON AS RF WAS TURNED ON. THE REPORTER STATED THAT THE MOVEMENT MIMICKED INSPIRATION/EXPIRATION. THE INDIFFERENT ELECTRODES WERE PLACED ON THE HIPS AWAY FROM ALL OTHER CABLES. FURTHER TROUBLESHOOTING WAS DECLINED TO PROCEED WITH THE CASE. THERE WAS NO ERROR GIVEN BY THE CARTO® 3 SYSTEM , THE SHIFT WAS A VISIBLE. THE ISSUE SEEN DURING ABLATION. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS 8 MM. THE PHYSICIAN DID NOT PERFORM CARDIOVERSION PRIOR TO THE MAP SHIFT AND THE PATIENT DID NOT MOVE BEFORE DETECTING THE SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913321 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC FG540000 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1