BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1033778 · Received April 25, 2008

    Report

    Report Number
    3004939290-2008-00025
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ACI FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE RETROPERITONEAL BLEED COULD NOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATIONS OR PERFORM AS INTENDED PER IFU. IN CONSIDERING POTENTIAL CAUSES, PER THE MYNX IFU, "DO NOT USE THE MYNX VASCULAR CLOSURE DEVICE IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED." IN ADDITION, PER THE MYNX IFU, THE SAFETY AND EFFECTIVENESS OF THE MYNX HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH BLEEDING DISORDERS SUCH AS THROMBOCYTOPENIA (PLATELET COUNT <100, 000/MM TO THE THIRD POWER), HEMOPHILIA, VON WILLEBRAND'S DISEASE OR ANEMIA (HGB <10G/DL, HCT < 30%).

    Description of Event or Problem · 1

    A FEMALE PATIENT WITH HISTORY OF BLEEDING DISORDER UNDERWENT AN UNCOMPLICATED ELECTIVE CATH IN 2008. THE MYNX DEVICE REPORTEDLY PERFORMED WITHOUT COMPLICATION AND HEMOSTASIS WAS ACHIEVED WITH NO SIGN OF SWELLING OR BLEEDING AT THE ACCESS SITE. ON THE NEXT DAY, A CT SCAN DOCUMENTED RETROPERITONEAL BLEED (SYMPTOMS UNKNOWN). THE PATIENT RECEIVED 4 UNITS OF BLOOD AND WAS SENT FOR SUCCESSFUL VASCULAR REPAIR. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WITHOUT FURTHER COMPLICATION. NO FURTHER INFORMATION WAS 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLAVIX.| MEDICATIONS INCLUDED ASA AND