BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 22212037 · Received June 16, 2025

    Report

    Report Number
    2124215-2025-38315
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 21, 2025
    Report Date
    August 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4-PREMARKET / 510(K) #: K111485, K170636 DEVICE EVALUATED BY MFR: THE FATHOM-16 GUIDEWIRE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTIONS REVEALED THE GUIDEWIRE WAS DETACHED AND PEELED AT THE DISTAL TIP.

    Additional Manufacturer Narrative · 0

    G4-PREMARKET / 510(K) #: K111485, K170636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT WAS PRESENTED WITH MELANOMA CANCER WITH METASTASIS TO THE LIVER. A 180X25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE TO GAIN ACCESS TO THE DISTAL LIVER WITH A NON-BOSTON SCIENTIFIC MICROCATHETER. UPON ADVANCING, THE INITIAL TREK OF THE WIRE WAS TORTUOUS, REQUIRING SIGNIFICANT TORQUING. HOWEVER, UPON TORQUING, THE TIP OF THE WIRE WAS NOT TORQUING ACCORDINGLY. THE WIRE WAS PULLED OUT AND THE DISTAL PIECE WAS MISSING. THE CATHETER WAS PULLED OUT WITH THE DISTAL PORTION STILL INTACT IN THE CATHETER. NEW CATHETER AND WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE ONLY NEGATIVE OUTCOME WAS THE LOSS OF ACCESS AND THE ADDITIONAL TIME ADDED TO THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT WAS PRESENTED WITH MELANOMA CANCER WITH METASTASIS TO THE LIVER. A 180X25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE TO GAIN ACCESS TO THE DISTAL LIVER WITH A NON-BOSTON SCIENTIFIC MICROCATHETER. UPON ADVANCING, THE INITIAL TREK OF THE WIRE WAS TORTUOUS, REQUIRING SIGNIFICANT TORQUING. HOWEVER, UPON TORQUING, THE TIP OF THE WIRE WAS NOT TORQUING ACCORDINGLY. THE WIRE WAS PULLED OUT AND THE DISTAL PIECE WAS MISSING. THE CATHETER WAS PULLED OUT WITH THE DISTAL PORTION STILL INTACT IN THE CATHETER. NEW CATHETER AND WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE ONLY NEGATIVE OUTCOME WAS THE LOSS OF ACCESS AND THE ADDITIONAL TIME ADDED TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503419 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035896161 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROGREAT CATHETER.| PROGREAT CATHETER.