BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET? SOLENT? OMNI

    MDR report key: 24214428 · Received January 29, 2026

    Report

    Report Number
    2124215-2026-05320
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889663
    PMA / PMN Number
    K111182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B, PRO CODE (PRODUCT CODE): DXE, KRA. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED TWO KINKS ON THE CATHETER SHAFT AT 43.2 AND 62.1 CM DISTAL TO THE STRAIN RELIEF. NO OTHER ABNORMALITIES WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED, AND THE CATHETER WAS ABLE TO BE PRIMED AND RUN, HOWEVER THE KINK IN THE SHAFT AT 62.1CM DISTAL TO THE STRAIN RELIEF DID HAVE A FLUID LEAK. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): DXE, KRA.

    Description of Event or Problem · 0

    IT WAS REPORTED LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT OMNI CATHETER WAS SELECTED FOR A FISTULA THROMBECTOMY PROCEDURE. DURING LOADING THE CATHETER OVER THE WIRE, A BEND/KINK WAS NOTED IN THE MIDDLE OF THE CATHETER, AND THE WIRE WAS DIFFICULT TO ADVANCE. A MICRO LEAK OF THE SALINE COMING FROM THE AREA OF THE KINK, AND A LOSS OF ASPIRATION WAS NOTED. THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT OMNI CATHETER WAS SELECTED FOR A FISTULA THROMBECTOMY PROCEDURE. DURING LOADING THE CATHETER OVER THE WIRE, A BEND/KINK WAS NOTED IN THE MIDDLE OF THE CATHETER, AND THE WIRE WAS DIFFICULT TO ADVANCE. A MICRO LEAK OF THE SALINE COMING FROM THE AREA OF THE KINK, AND A LOSS OF ASPIRATION WAS NOTED. THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559702 ANGIOJET? SOLENT? OMNI CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 109681-001 0037931791 08714729889663

    Patients

    Seq Age Sex Outcome Treatment
    1