BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1771023 · Received July 27, 2010

    Report

    Report Number
    3004939290-2010-00080
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. BASED UPON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED SEALANT MISDEPLOYMENT COULD NOT BE CONCLUSIVELY DETERMINED. IN ADDITION, WITHOUT SOURCE DOCUMENTATION OF A PATHOLOGY REPORT OR THE MATERIAL TO PERFORM CHEMICAL ANALYSIS, THE COMPOSITION OF THE OCCLUSION COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION. IT WAS REPORTED THAT HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE MYNX DEVICE. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT ACI IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL ON (B)(4) 2010 THAT A MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2010. FOLLOWING THE PROCEDURE, MYNX WAS USED FOR FEMORAL ARTERIAL CLOSURE. THERE WERE NO REPORTS OF COMPLICATIONS DURING THE PROCEDURE OR CLOSURE. HEMOSTASIS WAS ACHIEVED AND THE PATIENT WAS AMBULATED AND DISCHARGED PER HOSPITAL PROTOCOL. ON (B)(6) 2010, THE PATIENT RETURNED FOR A FOLLOW UP PROCEDURE TO HAVE A STENT PLACED. POST PROCEDURE AND PRIOR TO CLOSURE, A FEMORAL ANGIOGRAM TAKEN REVEALED THROMBUS IN THE COMMON FEMORAL ARTERY (CFA). THE PHYSICIAN OPTED TO CLOSE WITH MANUAL COMPRESSION. THE PATIENT WAS ADMITTED AND TREATED WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) FOR 2 DAYS. THE TPA TREATMENT WAS UNSUCCESSFUL AND THE PATIENT WAS TAKEN TO THE OR FOR A CUT DOWN ON (B)(6) 2010. THE SURGEON REMOVED WHAT WAS BELIEVED TO BE THE MYNX SEALANT. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 WITHOUT FURTHER CLINICAL SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TISSUE PLASMINOGEN ACTIVATOR