BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM? -16

    MDR report key: 25216884 · Received May 19, 2026

    Report

    Report Number
    2124215-2026-26806
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729762553
    PMA / PMN Number
    K111485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. DURING AN ANGIOGRAM PROCEDURE, THE TARGET BRANCH HAD TWO SHARP TURNS AND WAS ACCESSED WITH A NON- BSC MICROCATHETER. INITIAL ATTEMPTS USING A FATHOM-14 GUIDEWIRE WERE UNSUCCESSFUL AS IT COULD NOT BE ADVANCED; THEREFORE, A FATHOM-16 GUIDEWIRE WAS USED. THE FATHOM-16 WAS RESHAPED TWICE, AND RESISTANCE WAS FELT DURING MANIPULATION WITHIN THE MICROCATHETER. WHILE WITHDRAWING THE FATHOM-16 GUIDEWIRE TO ATTEMPT AN ALTERNATIVE GUIDEWIRE, THE TIP DETACHED AND REMAINED INSIDE THE MICROCATHETER. THE MICROCATHETER SYSTEM WAS SUBSEQUENTLY REMOVED WITH THE GUIDEWIRE TIP RETAINED WITHIN IT. A SECOND FATHOM-16 GUIDEWIRE WAS USED, AND MINOR CURVES WERE PLACED IN THE WIRE; HOWEVER, IT ALSO EXHIBITED RESISTANCE AFTER SEVERAL MINUTES. UPON REMOVAL, A DEFORMITY AND WHAT APPEARED TO BE A BREAKAGE WERE OBSERVED IN THE SAME REGION AS THE PREVIOUS WIRE ISSUE. THE PROCEDURE CONTINUED USING A FATHOM-14 WIRE, AND NO FURTHER COMPLICATIONS OCCURRED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248472 FATHOM? -16 WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION M001509100 0038463194 08714729762553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown