BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 22020882 · Received May 14, 2025

    Report

    Report Number
    2124215-2025-29482
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: USED (B)(6) 2025 AS THE EVENT DATE WAS NOT REPORTED. G4 - PREMARKET / 510(K) #: K111485, K170636. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO RETRIEVE DEVICE STATUS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH (B)(4)THAT DEVICE BROKE INSIDE THE CATHETER. A 180X25CM FATHOM? -16 GUIDEWIRE WAS SELECTED FOR IMAGE-GUIDED HEPATIC ANGIOGRAPHY AND MAPPING WITH TRANSCATHETER EMBOLIZATION. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE BROKE INSIDE THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882212 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035627349 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male