BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACLIP

    MDR report key: 24855944 · Received April 13, 2026

    Report

    Report Number
    2020394-2026-00916
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 20, 2026
    Report Date
    March 24, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    GDW
    UDI-DI
    00801741032295
    PMA / PMN Number
    K042341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (NEU; GDW). SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH HARD DENSITY TISSUE USING ULTRACLIP TISSUE MARKER DEVICE. DURING THE PROCEDURE, THE DEVICE CLIP COMING LOOSE. NO COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921682 ULTRACLIP BIOPSY INSTRUMENT GDW BARD PERIPHERAL VASCULAR, INC. HUHX0341 00801741032295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown