BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FATHOM? -16

    MDR report key: 21882449 · Received April 22, 2025

    Report

    Report Number
    2124215-2025-23951
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 22, 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
    FL, 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 TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 180X25CM FATHOM -16 WAS SELECTED FOR USE IN A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL FLOPPY PORTION (25CM DISTAL PART) SHEARED OFF AND THE PIECE WAS VISIBLE UNDER FLUOROSCOPY NEAR HEPATIC ARTERY. THE WIRE WAS ATTEMPTED TO BE REMOVED, HOWEVER WAS UNSUCCESSFUL. THEREFORE, AN ACCESS WAS MADE TO THE LEFT FEMORAL ARTERY, MOVED MICROSNARE INTO THE AORTA AND WAS ABLE TO SNARE THE WIRE. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015464 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0035623336 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention