BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIREXION¿ HI-FLO¿

    MDR report key: 22622806 · Received July 28, 2025

    Report

    Report Number
    22622806
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    08714729839521
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE WIRE WITHIN MICROCATHETER WAS FOUND BROKEN DURING PREP OF THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH NO REPORTED HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR MICROCATHETER, 2.8FR DISTAL OD X 155CM DIREXION HI-FLO TORQUEABLE MICROCATHETER, BERN TIP, 0.02 (PER SITE REPORTER). MFG [MANUFACTURER] NOTIFIED BY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100060 DIREXION¿ HI-FLO¿ CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION M001195450 32431062 08714729839521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown