BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 22816837 · Received August 15, 2025

    Report

    Report Number
    2124215-2025-56167
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    June 12, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET/510(K)#- K111485, K170636. THE DEVICE WAS RETURNED FOR ANALYSIS. UPON EXAMINATION, THE GUIDEWIRE, WHICH WAS RETURNED ATTACHED TO THE TORQUER DEVICE, SHOWED DETACHMENT AT THE DISTAL TIP. THE DISTAL TIP WAS FOUND TO BE SEPARATED FROM THE GUIDEWIRE.

    Description of Event or Problem · 0

    REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 22JUL2025. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LIVER. A 180X25CM FATHOM? -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, A SMALL PROTRUSION OR IRREGULARITY WAS NOTED AT THE END OF THE DEVICE, WHICH PREVENTED IT FROM PROPERLY ENGAGING WITH THE TRUSELECT. AS A RESULT, THE DEVICE COULD NOT BE LOADED INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING WITH AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DETACHED AT DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239953 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035924443 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown