BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION?

    MDR report key: 21873019 · Received April 21, 2025

    Report

    Report Number
    2124215-2025-23971
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 27, 2025
    Report Date
    May 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839354
    PMA / PMN Number
    K142259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K): K142259, K163701.

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K): K142259, K163701. DEVICE EVALUATED BY MFR: THE DIREXION WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPE EXAMINATION WERE PERFORMED. IT REVEALED NICKEL SHAFT FRACTURE AND AN INNER LUMEN KINK APPROXIMATELY 27.5CM FROM THE STRAIN RELIEF. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN A RENAL ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION. DURING THE PROCEDURE, UPON ADVANCING/RETRACTING AND TRYING TO ACCESS, THE CATHETER BROKE. THE DEVICE WAS SIMPLY REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A DIREXION MICROCATHETER WAS SELECTED FOR USE IN A RENAL ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION. DURING THE PROCEDURE, UPON ADVANCING/RETRACTING AND TRYING TO ACCESS, THE CATHETER BROKE. THE DEVICE WAS SIMPLY REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518351 DIREXION? CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195240 0033215224 08714729839354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown