BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 8263033 · Received January 19, 2019

    Report

    Report Number
    2029046-2019-02588
    Event Type
    Malfunction
    Date Received
    January 19, 2019
    Date of Event
    December 26, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO® 3 SYSTEM. IT WAS REPORTED THAT 2 SECONDS AFTER COMPLETION OF A PACING TRAIN WHILE USING A JLL 5FR, 10 POLE CATHETER THROUGH THE CARTO 3 SYSTEM, AN UNDESIRED DISCHARGE OCCURRED. THERE IS NO EVIDENCE THAT THE ADDITIONAL PACING TRIGGERED AN ARRHYTHMIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY EVEN THOUGH THE ISSUE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. AFTER THE STIMULATION ENDS THERE IS AN ADDITIONAL PULSE ABOUT 2 SECONDS AFTER THE LAST STIMULATION EVENT. THIS PULSE IS AN ARTIFACT ON THE SIGNAL, BUT NOT REAL PACING. THE REPORTED ISSUE IS RELATED TO A SOFTWARE DEFECT. THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER CONFIRMED THAT THE ISSUE WAS EXPLAINED AND UNDERSTOOD BY THE CUSTOMER THAT THERE WAS NO IMPACT ON PATIENT. SYSTEM IS OPERATIONAL. THE DEVICE HISTORY RECORD 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 1/28/2019 STATING THAT THE PACING STIMULATOR USED DURING THE PROCEDURE WAS THE FUKUDA ELECTRONICS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURED DATE WAS PROVIDED ON (B)(6)2019. THEREFORE, MANUFACTURED DATE HAS BEEN POPULATED. MANUFACTURER'S REFERENCE NUMBER: (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. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO® 3 SYSTEM AND THERE WAS AN UNWANTED PACING ISSUE. IT WAS REPORTED THAT 2 SECONDS AFTER COMPLETION OF A PACING TRAIN WHILE USING A JLL 5FR, 10 POLE CATHETER THROUGH THE CARTO 3 SYSTEM, AN UNDESIRED DISCHARGE OCCURRED. THERE IS NO EVIDENCE THAT THE ADDITIONAL PACING TRIGGERED AN ARRHYTHMIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY EVEN THOUGH THE ISSUE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE UNWANTED PACING ISSUE WAS ASSESSED AS A REPORTABLE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55827 CARTO® 3 SYSTEM SIMILAR DEVICE FG540000, 510K # K042999 DQK BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1