BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM -16

    MDR report key: 20833979 · Received December 3, 2024

    Report

    Report Number
    2124215-2024-75518
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 11/01/2024 AS THE EXACT EVENT DATE WAS NOT REPORTED. G4 - ADDITIONAL PREMARKET / 510(K): K170636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 180X25CM FATHOM -16 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FATHOM BROKE OFF IN THE RENEGADE MICROCATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291436 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0034821665 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown