BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM -16

    MDR report key: 20865595 · Received December 6, 2024

    Report

    Report Number
    2124215-2024-74137
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 1, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: USED 11/01/2024 AS THE EVENT DATE WAS NOT REPORTED. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K111485, K170636. DEVICE EVAL BY MFR: THE DEVICE WAS NOT RETURNED. HOWEVER, A PHOTO WAS PROVIDED FROM THE HEALTHCARE FACILITY. IT WAS OBSERVED THAT THE DISTAL TIP DETACHED.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: USED (B)(6) 2024 AS THE EVENT DATE WAS NOT REPORTED. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K111485, K170636.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A 180X25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT ABOUT 15CM OF THE TIP HAD BROKEN OFF IN THE RENAL ARTERY. A PORTION OF THE BROKEN TIP REMAINED IN THE MICROCATHETER, AND EVERYTHING WAS ABLE TO BE PULLED OUT SAFELY. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A 180X25CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT ABOUT 15CM OF THE TIP HAD BROKEN OFF IN THE RENAL ARTERY. A PORTION OF THE BROKEN TIP REMAINED IN THE MICROCATHETER, AND EVERYTHING WAS ABLE TO BE PULLED OUT SAFELY. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084568 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0034727809 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown