BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM -16

    MDR report key: 20925079 · Received December 13, 2024

    Report

    Report Number
    2124215-2024-74776
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 19, 2024
    Report Date
    January 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - ADDITIONAL PREMARKET / 510(K): K170636. DEVICE EVALUATED BY MFR: THE GUIDEWIRE WAS RETURNED, AND IT WAS OBSERVED THAT IT WAS DETACHED/PEELED AT POLYMER JACKET AND BENT AT DISTAL TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    G4 - ADDITIONAL PREMARKET / 510(K): K170636

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COATING ISSUE OCCURRED. A 180X25CM FATHOM -16 GUIDEWIRE WAS USED FOR TRANSARTERIAL EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE MICROCATHETER THROUGH THE FATHOM WIRE. THE PHYSICIAN WITHDREW BOTH THE WIRE AND MICROCATHETER AND SUSPECTING THAT THE WIRE COATING HAD SPLIT DUE TO AN UNEVEN SURFACE. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COATING ISSUE OCCURRED. A 180X25CM FATHOM -16 GUIDEWIRE WAS USED FOR TRANSARTERIAL EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE MICROCATHETER THROUGH THE FATHOM WIRE. THE PHYSICIAN WITHDREW BOTH THE WIRE AND MICROCATHETER AND SUSPECTING THAT THE WIRE COATING HAD SPLIT DUE TO AN UNEVEN SURFACE. THE PROCEDURE WAS COMPLETED WITH THE ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416635 FATHOM -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0033656971 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown