BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIREXION? FATHOM?-16 SYSTEM

    MDR report key: 25318077 · Received May 28, 2026

    Report

    Report Number
    2124215-2026-28626
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839644
    PMA / PMN Number
    K142259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K142259, K163701. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A REVIEW OF THE DIREXION DEVICE CONFIRMED THAT THE REPORTED EVENT IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FRACTURED AND DETACHED, REQUIRING INTERVENTION. A DIREXION? FATHOM?-16 SYSTEM CATHETER WAS USED FOR ABDOMINAL EMBOLIZATION TO TREAT A HEMORRHAGE. AFTER INJECTING THE EMBOLIZATION MATERIAL INTO THE TARGET VESSEL, THE CATHETER BECAME STUCK, COULD NOT BE WITHDRAWN FROM THE BODY, AND FRACTURED DURING GENTLE TRACTION. THE OUTER NITINOL SEGMENT BROKE AT THE PROXIMAL ASPECT, RESULTING IN EXPOSURE OF THE INNER COMPONENT. THE NITINOL SEGMENT OF THE CATHETER REMAINED INSIDE THE VESSEL, WHILE THE REMAINING PORTION OF THE CATHETER WAS REMOVED. A GOOSE NECK SNARE WAS USED AND AFTER SEVERAL ATTEMPTS, WAS ABLE TO RETRIEVE THE NITINOL SEGMENT FROM THE PATIENT. THE PROCEDURE WAS PROLONGED, BUT THERE WERE NO COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358883 DIREXION? FATHOM?-16 SYSTEM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195650 0038769971 08714729839644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention