BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FATHOM STRAIGHT TIP STEERABLE GU

    MDR report key: 17059097 · Received June 2, 2023

    Report

    Report Number
    MW5118134
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    May 23, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729801023
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING EMERGENT PROCEDURE TO EMBOLIZE AN ACUTE BLEED, END OF FATHOM WIRE BROKE OFF AND REMAINS IN THE BODY. PATIENT WAS DNR(DO NOT RESUSCITATE), IT WAS FELT TO BE MORE DANGEROUS TO ATTEMPT TO RETRIEVE THE FOREIGN OBJECT VERSUS LEAVING IT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676178 FATHOM STRAIGHT TIP STEERABLE GU WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001508100 31186223 08714729801023

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Life Threatening