BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FATHOM -16

    MDR report key: 21620552 · Received March 17, 2025

    Report

    Report Number
    2124215-2025-14395
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED AND LEFT UNRETRIEVABLE INSIDE THE PATIENT'S BODY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ATHEROSCLEROTIC M1 OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY. A 180X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A FRACTURED SEGMENT OF THE DISTAL GUIDEWIRE WHICH REMAINS IN PLACE WITHIN THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY EXTENDING BACK INTO THE DISTAL RIGHT INTERNAL CAROTID ARTERY. ATTEMPTS TO SNARE THE FRACTURED GUIDEWIRE WERE UNSUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4670 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035349595 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R