BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPRA VASCULAR GRAFT

    MDR report key: 17403502 · Received July 27, 2023

    Report

    Report Number
    2020394-2023-00536
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 11, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DYF
    UDI-DI
    00801741023361
    PMA / PMN Number
    K004012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H10: D4 (EXPIRY DATE: 08/2027). H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST A SURGICAL GRAFT PLACEMENT PROCEDURE, THE BLOOD VESSELS ALLEGEDLY LEAKED BLOOD. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662660 IMPRA VASCULAR GRAFT EPTFE VASCULAR GRAFT DYF BARD PERIPHERAL VASCULAR, INC. VTGV0557 00801741023361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown