BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPRA EPTFE VASCULAR GRAFT

    MDR report key: 24554738 · Received March 10, 2026

    Report

    Report Number
    2020394-2026-00625
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 15, 2026
    Report Date
    May 4, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    UDI-DI
    00801741021350
    PMA / PMN Number
    K004011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS AND VIDEOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (DYF; DSY). SECTION A THROUGH F: THE INFORMATION PROVIDED 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 A SURGICAL GRAFT PLACEMENT PROCEDURE USING A CARBOFLO DEVICE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE RING ON THE GRAFT ALLEGEDLY FELL OFF, CAUSING THE BLOOD TO LEAK FROM THE GRAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250226 IMPRA EPTFE VASCULAR GRAFT EPTFE VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. VTJU0275 00801741021350

    Patients

    Seq Age Sex Outcome Treatment
    1