BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION?

    MDR report key: 24323255 · Received February 12, 2026

    Report

    Report Number
    2124215-2026-07710
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    December 19, 2025
    Report Date
    March 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839415
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1: MFR SITE ZIP/POST CODE: T12 YK88. G4: PMA/510(K) # FIELD IS K142259, K163701 - REPORTED HERE AS THE PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. E1: INITIAL REPORTER PHONE: (B)(6).

    Additional Manufacturer Narrative · 0

    G1: MFR SITE ZIP/POST CODE: T12 YK88. G4: PMA/510(K) # FIELD IS K142259, K163701 - REPORTED HERE AS THE PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. E1: INITIAL REPORTER PHONE: (B)(6). DEVICE HISTORY RECORDS (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. DEVICE TECHNICAL ANALYSIS: THE RETURNED DEVICE CONSISTS OF A DIREXION MICROCATHETER IN TWO PIECES, WHERE THE SHAFT IS SEPARATED FROM THE HUB. VISUAL EXAMINATION REVEALED A NICKEL SHAFT FRACTURE AT THE HUB AND THE INNER LUMEN DETACHED FROM THE HUB. ANOTHER NICKEL SHAFT FRACTURE IS LOCATED APPROXIMATELY 44CM FROM THE PROXIMAL END. THE INNER LUMEN STRETCH IS LOCATED APPROXIMATELY 44CM TO 48.5CM FROM THE PROXIMAL END. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW STATEMENT: A RISK REVIEW PERFORMED FOR THE DIREXION DEVICE CONFIRMED THAT THE REPORTED EVENTS ARE KNOWN EVENTS DEFINED IN THE PRODUCTS RISK MANAGEMENT DOCUMENTATION. THIS EVENT HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC CONCLUDES THE MOST PROBABLE ROOT CAUSE AS CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FRACTURE OCCURRED. A DIREXION WAS SELECTED FOR USE IN A PROSTATE ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE DIREXION FRACTURED AT THE DISTAL END. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FRACTURE OCCURRED. A DIREXION WAS SELECTED FOR USE IN A PROSTATE ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE DIREXION FRACTURED AT THE DISTAL END. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254977 DIREXION? CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195300 0037775263 08714729839415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown