BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 24039229 · Received January 12, 2026

    Report

    Report Number
    2124215-2026-01837
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    November 11, 2025
    Report Date
    January 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K111485, K170636. DEVICE EVALUATED BY MFR: THE GW FATHOM PERIPH DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL AND MICROSCOPIC INSPECTION IDENTIFIED THAT THE DISTAL TIP IS KINKED, DETACHED AND UNRAVELED. ALSO, THE GUIDEWIRE COATING IS PEELED. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT THE DISTAL END OF THE GUIDEWIRE APPEARED BROKEN. THE TARGET LESION WAS LOCATED IN THE LIVER. A 180X25CM FATHOM 16 WAS SELECTED FOR USE TO TREAT LIVER CANCER IN A Y-90 MAPPING PROCEDURE. DURING THE PROCEDURE, THE DISTAL END OF THE GUIDEWIRE APPEARED BROKEN BUT REMAINED INTACT. THE GUIDEWIRE WAS PULLED OUT OF THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106336 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0037476912 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown