BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARASTAR

    MDR report key: 24663016 · Received March 23, 2026

    Report

    Report Number
    2124215-2026-15756
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    February 1, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FARASTAR MSM NAM WAS SELECTED FOR USE. IT HAS BEEN MENTIONED THAT THE FIRST ISSUE WAS MAP SHIFTING WITHOUT PATIENT MOVEMENT. TRIED TO ADJUST THE MAGNET PHYSICALLY TO LINE UP THE MAP YET NO IMPROVEMENT. SECOND ISSUE WAS THAT WHILE ABLATING, CATHETER STARTED TO DISAPPEAR ON THE SCREEN AFTER ABOUT 50-60 ABLATIONS. MAP SHIFT ISSUE OCCURRED AGAIN. USING AN EXTERNAL REFERENCE AND IT WAS ROUTED THROUGH THE RSM. DURING ONE OF THE CASES DURING THE PROCEDURE, A LAB STAFF MEMBER PLACED THE BAYLIS GENERATOR ON TOP OF THE MSM. NO ERRORS OCCURRED ON THE OPAL SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED. THE PROCEDURE WAS CANCELLED. THE PRODUCT IS NOT EXPECTED TO BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726213 FARASTAR No Match QZI BOSTON SCIENTIFIC CORPORATION M004PF61M601 0107874039 00191506043841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown