BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1241626 · Received November 18, 2008

    Report

    Report Number
    3004939290-2008-00102
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 18, 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 FOR EVALUATION, HOWEVER, THE LOT NUMBER WAS PROVIDED. BASED ON THE LIMITED INFO AND THE LOT HISTORY REVIEW THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT PERFORM AS INTENDED AND THE ROOT CAUSE OF THE REPORTED INCIDENT IS UNK. PRIOR TO THE ANGIOPLASTY, THE PATIENT WAS SCHEDULED FOR A TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS THAT WAS POSTPONED DUE TO THE ANGIOPLASTY PROCEDURE THAT WAS PERFORMED IN 2008. CIRRHOSIS OF THE LIVER MAY IMPACT NORMAL COAGULATION AND THE BODY'S ABILITY TO CLOT EFFECTIVELY. ALTHOUGH REQUESTED, ADDITIONAL LAB RESULTS OF THE PATIENT'S BASELINE BLOOD COUNTS WERE NOT PROVIDED.

    Description of Event or Problem · 1

    A MAPLE PATIENT, ANEMIC, WITH EXCESSIVE ADIPOSE TISSUE AND WITH HISTORY OF CIRRHOSIS OF THE LIVER, UNDERWENT PTA IN 2008. BI-LATERAL ACCESS SITES WERE MADE AND A 6 FR PROCEDURAL SHEATH WAS PLACED IN THE LEFT COMMON FEMORAL ARTERY (CFA) IN A RETROGRADE FASHION AND A 7 FR ARROW SHEATH PLACED IN THE RIGHT CFA IN AN ANTEGRADE APPROACH. AT THE END OF THE PTA, THE PHYSICIAN, IN TRAINING, PREPPED AND SUCCESSFULLY DEPLOYED A MYNX VASCULAR CLOSURE DEVICE AT THE RIGHT CFA TO ACHIEVE HEMOSTASIS. FOLLOWING SUCCESSFUL HEMOSTASIS AT THE RIGHT CFA, THE PHYSICIAN PREPPED AND DEPLOYED A MYNX DEVICE AT THE LEFT CFA. UPON COMPLETION OF DEVICE DEPLOYMENT, NOTABLE SWELLING WAS PRESENT AT THE LEFT ACCESS SITE. MANUAL COMPRESSION WAS APPLIED BUT WAS UNSUCCESSFUL IN CONTROLLING THE SWELLING. PERCUTANEOUS ACCESS WAS GAINED A SECOND TIME FROM THE RIGHT CFA IN ORDER TO VISUALIZE THE LEFT CFA. A SMALL PUNCTURE WAS NOTED WITH EXTRAVASATION THAT WAS TEMPORARILY CONTROLLED BY WAY OF CREATING A TAMPONADE WITH A BALLOON CATHETER. THE PT WAS SENT FOR SURGICAL EVACUATION OF THE HEMATOMA AND REPAIR OF A SINGLE ANTERIOR WALL FEMORAL ARTERY PUNCTURE. THE PATIENT ALSO RECEIVED A TRANSFUSION OF 5 UNITS OF PACKED RED BLOOD CELLS. THE PATIENT TOLERATED THE PROCEDURE WELL AND RECOVERED WITHOUT FURTHER CLINICAL SEQUELAE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX MGB ACCESSCLOSURE, INC MX6700 F0823404

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R ANGIOMAX