BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 23301257 · Received October 15, 2025

    Report

    Report Number
    2124215-2025-72289
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 12, 2025
    Report Date
    December 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K111485, K170636. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS,, AND THE EVALUATION WAS COMPLETED. VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT THE DISTAL TIP WAS RETURNED DETACHED, BUT THE DETACHED SECTION WAS NOT RETURNED FOR ANALYSIS. THE DEVICE WAS INSPECTED UNDER MAGNIFICATION, AND IT WAS POSSIBLE TO SEE THAT THE DISTAL TIP WAS DETACHED, AND THE CORE WIRE WAS KINKED. ADDITIONALLY, THE POLYTETRAFLUOROETHYLENE (PTFE) COATING AT THE PROXIMAL SECTION WAS PEELED. SINCE A DETACHMENT OCCUR AND THE REST OF THE TIP DID NOT RETURN FOR ANALYSIS, A DIMENSIONAL INSPECTION WAS NOT ABLE TO BE CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WIRE STUCK AND FRACTURED OCCURRED. A 16 .016 PERPH GW 180X25CM FATHOM WAS SELECTED FOR USE IN A PSEUDO ANEURYSM EMBOLIZATION. DURING THE PROCEDURE, THE WIRE DID NOT MAINTAIN ITS SHAPE AFTER MANUAL SHAPING. UPON INSERTION INTO THE MICROCATHETER, RESISTANCE WAS NOTED. WHEN THE FATHOM WIRE WAS SUBSEQUENTLY WITHDRAWN, IT INITIALLY APPEARED STUCK, THEN RELEASED ABRUPTLY AND FRACTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WIRE STUCK AND FRACTURED OCCURRED. A 16 .016 PERPH GW 180X25CM FATHOM WAS SELECTED FOR USE IN A PSEUDO ANEURYSM EMBOLIZATION. DURING THE PROCEDURE, THE WIRE DID NOT MAINTAIN ITS SHAPE AFTER MANUAL SHAPING. UPON INSERTION INTO THE MICROCATHETER, RESISTANCE WAS NOTED. WHEN THE FATHOM WIRE WAS SUBSEQUENTLY WITHDRAWN, IT INITIALLY APPEARED STUCK, THEN RELEASED ABRUPTLY AND FRACTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994144 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0037153122 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown