BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER

    MDR report key: 11708093 · Received April 22, 2021

    Report

    Report Number
    2134265-2021-05177
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT TWO HOURS INTO AN ABLATION PROCEDURE USING INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER THE TEMPERATURE SENSOR FAILED. THE TEMPERATURE WAS STATED TO BE ABOUT 42 DEGREES CELSIUS EVEN THOUGH ENERGIZATION COULD NOT BE PERFORMED AT THE TIME. NO ERROR MESSAGE WAS DISPLAYED. THE GENERATOR WAS IN POWER CONTROL MODE AND THE ABLATION WAS PERFORMED AT 30W FOR THE POWER SETTING. THEY EXCHANGED THE CATHETER AND THE ISSUE WAS RESOLVED. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602716 INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION 87047 0024944582

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR