BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 23810178 · Received December 15, 2025

    Report

    Report Number
    2124215-2025-90941
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    October 9, 2025
    Report Date
    December 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 FOR EVALUATION. VISUAL AND MICROSCOPE INSPECTIONS WERE PERFORMED. IT WAS POSSIBLE TO SEE THAT THE GUIDEWIRE WAS KINKED. ALSO, THE PTFE COATING AT THE PROXIMAL SECTION WAS PEELED. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11NOV2025. IT WAS REPORTED THAT WIRE WAS BENT. A 180X25CM FATHOM? 16 WAS SELECTED FOR USED. DURING UNPACKING, IT WAS NOTED THAT THE WIRE WAS BENT. THERE WERE NO COMPLICATION AS THE RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING AT THE PROXIMAL SECTION WAS PEELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273370 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0037071048 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown