BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FATHOM? -16

    MDR report key: 23486852 · Received November 6, 2025

    Report

    Report Number
    2124215-2025-78732
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 27, 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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD H6: DEVICE CODES FROM FRACTURE TO DETACHMENT OF DEVICE OR DEVICE COMPONENT G4: PREMARKET / 510(K): K111485, K170636. E1: INITIAL REPORTER PHONE: (B)(4).

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K111485, K170636. E1: INITIAL REPORTER PHONE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. DURING A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE INVOLVING THE LIVER, A 180 CM X 25 CM FATHOM-16 GUIDEWIRE WAS USED FOR SUPER-SELECTION. THE TARGET VESSEL EXHIBITED MODERATE TORTUOSITY AND NO CALCIFICATION. DURING USE, THE GUIDEWIRE FRACTURED WITHIN THE BLOOD VESSEL, SEPARATING INTO TWO PIECES. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FRACTURED SEGMENT USING A CATCHER DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE, WITH NO REPORTED COMPLICATIONS OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. DURING A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE INVOLVING THE LIVER, A 180 CM X 25 CM FATHOM-16 GUIDEWIRE WAS USED FOR SUPER-SELECTION. THE TARGET VESSEL EXHIBITED MODERATE TORTUOSITY AND NO CALCIFICATION. DURING USE, THE GUIDEWIRE FRACTURED WITHIN THE BLOOD VESSEL, SEPARATING INTO TWO PIECES. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FRACTURED SEGMENT USING A CATCHER DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE, WITH NO REPORTED COMPLICATIONS OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465439 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0034303926 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention