BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE 2.0 NAV

    MDR report key: 24770213 · Received April 2, 2026

    Report

    Report Number
    2124215-2026-17897
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AT THE TIME OF THE SUBMISSION OF THIS REPORT, AS IT WAS NOT YET AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FARAWAVE CATHETER PRESENTED THE ERROR BADHDR AND WHEN IT WAS DISCONNECTED THE FLUSH PORT BROKE. A FARAWAVE 2.0 NAV WAS SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. THE ERROR BADHDR OCCURRED, HENCE THE CABLE WAS DISCONNECTED FROM CATHETER TO MSM, AND RECONNECTED, WHICH DID NOT SOLVE THE PROBLEM. THE ERROR CHANGED TO NO SYSTEM REFERENCE, THEN DISCONNECTED CABLE FROM CATHETER TO MSM AGAIN, TURNED OFF MSM, WAITED 5 SECONDS, TURNED MSM BACK ON AND THE CATHETER WAS RECONNECTED. IT WAS NEEDED TO REPLACED THE CATHETER. THEREFORE, IT WAS NOTE THAT SIDE PORT GOT DAMAGED AFTER CATHETER WAS REPLACED. LATER, IT WAS NOTED THAT THE FLUSHING PORT OF THE CATHETER BROKE WHEN DISCONNECTING AFTER ERROR OCCURRED. THERE WERE NO INFORMATION AVAILABLE INDICATING THE SIDE PORT WAS DEFECTIVE UPON OPENING. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832305 FARAWAVE 2.0 NAV No Match QZI BOSTON SCIENTIFIC CORPORATION 0038255941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown