BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 24081674 · Received January 15, 2026

    Report

    Report Number
    2124215-2026-02768
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    October 27, 2025
    Report Date
    January 15, 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 BROKEN AND BENT, AND THE GUIDEWIRE IS KINKED AT THE PROXIMAL SECTION. ALSO, THE COATING IS PEELED. HOWEVER, THE TIP DID NOT RETURN DETACHED ONLY BROKEN. THIS CONCLUDES THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT KINK OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 180X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A BREAK AND A KINK NOTED 15CM IN THE DISTAL END OF THE GUIDEWIRE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT, 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 THE COATING IS PEELED AND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143015 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0036900475 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown