BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1055876 · Received June 2, 2008

    Report

    Report Number
    3004939290-2008-00044
    Event Type
    Injury
    Date Received
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ACI FOR EVALUATION, AND THE LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE BY ACCESS CLOSURE, INC. TO OBTAIN ADD'L PT AND PROCEDURAL INFO. BASED ON THE INFO PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE PSEUDOANEURYSM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT A PT UNDERWENT A CATHETERIZATION PROCEDURE DURING THE MONTH IN WHICH THE MYNX DEVICE WAS USED. POST PROCEDURE, THE PT WAS DIAGNOSED WITH A PSEUDOANEURYSM REQUIRING VASCULAR REPAIR. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL PT AND PROCEDURAL INFO. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. MX6700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention