BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FATHOM -16

    MDR report key: 16492705 · Received March 6, 2023

    Report

    Report Number
    2124215-2023-09615
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    February 8, 2023
    Report Date
    May 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K170636
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MANUFACTURER: THIS 180X25CM FATHOM-16 GUIDEWIRE WAS RECEIVED FOR ANALYSIS. THE RETURNED DEVICE WAS FOUND STUCK INSIDE A TORQUE DEVICE. MICROSCOPIC AND VISUAL INSPECTION REVEALED THE GUIDEWIRE AND POLYMER JACKET WERE FRACTURED AT THE DISTAL SECTION, WHICH CONFIRMS THE ALLEGATION FROM THE FIELD OF DETACHMENT OF THE DISTAL TIP. CORRECTION TO FIELD H6: DEVICE CODE FRACTURE A040101 WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE GUIDEWIRE FRACTURED AND THE DISTAL TIP REMAINS IN THE PATIENT. THIS 180X25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE DURING THIS INDEX PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE RUPTURED, AND THE DISTAL TIP MIGRATED INTO THE HYPOGASTRIC ARTERY. THE FRAGMENT WAS NOT ABLE TO BE REMOVED SAFELY, SO WAS LEFT UNRETRIEVED INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE GUIDEWIRE FRACTURED AND THE DISTAL TIP REMAINS IN THE PATIENT. THIS 180X25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE DURING THIS INDEX PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE RUPTURED AND THE DISTAL TIP MIGRATED INTO THE HYPOGASTRIC ARTERY. THE FRAGMENT WAS NOT ABLE TO BE REMOVED SAFELY, SO WAS LEFT UNRETRIEVED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64087 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 81720 0030565449 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other