BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM 16

    MDR report key: 21791253 · Received April 7, 2025

    Report

    Report Number
    2124215-2025-20421
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 4, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    G4-PREMARKET / 510(K) #: K111485, K170636. DEVICE EVALUATED BY MFR: THE FATHOM 16 WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPE INSPECTIONS WERE PERFORMED. IT WAS OBSERVED THAT THE DISTAL TIP WAS DETACHED, STRETCHED AND BENT. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 180 X 25 CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE FRAYED AND BROKE OFF IN A PATIENT. THE WIRE WAS RETRIEVED, THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 180X25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE FRAYED AND BROKE OFF IN A PATIENT. THE WIRE WAS RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980062 FATHOM 16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035114417 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown