BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT GRAFTS < 6MM

    MDR report key: 3883753 · Received June 10, 2014

    Report

    Report Number
    1219977-2014-00173
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    DYF
    PMA / PMN Number
    K992958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE F/U REPORT ONCE THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THE TIP OF THE DELIVERY SYSTEM SLIDER DETACHED DURING CREATION OF THE FOREARM LOOP FISTULA. AFTER TUNNELING, THE VEIN OF THE DELIVERY SYSTEM DISCONNECTED FROM THE TUNNELER. THE TIP OF DELIVERY SYSTEM WAS REATTACHED TO THE TUNNELER PRIOR TO TUNNELING THE ARTERY. THE PROCEDURE WAS COMPLETED BY SUTURING THE GRAFT ONTO THE TUNNELER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342099 ADVANTA VXT GRAFTS < 6MM PROSTHESIS VASCULAR GRAFT < 6MM DYF ATRIUM MEDICAL CORPORATION 22016 10911114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention