BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 24695497 · Received March 26, 2026

    Report

    Report Number
    2020394-2026-00727
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 5, 2026
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    UDI-DI
    00801741023613
    PMA / PMN Number
    K983861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (DSY; DYF). 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 IMPLANTATION PROCEDURE BY USING THE DISTAFLO BYPASS GRAFT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GRAFT ALLEGEDLY FRAYED AFTER BEING SEWN IN PLACE AND PRESSURIZED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757160 DISTAFLO BYPASS GRAFT EPTFE VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. VTJW0236 00801741023613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown