BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1894523 · Received November 9, 2010

    Report

    Report Number
    3004939290-2010-00118
    Event Type
    Injury
    Date Received
    November 9, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED UPON THE LIMITED INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED SEALANT MISDEPLOYMENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE WAS NO INFORMATION PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX AND ITS USE PER THE INSTRUCTIONS FOR USE. ADDITIONALLY, WITHOUT SOURCE DOCUMENTATION OF A PATHOLOGY REPORT OR THE MATERIAL TO PERFORM CHEMICAL ANALYSIS, THE COMPOSITION OF THE OCCLUSION COULD NOT BE CONCLUSIVELY DETERMINED. 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 FEMALE PATIENT EXPERIENCED COMPLICATIONS FOLLOWING A RIGHT AND LEFT HEART CATHETERIZATION PROCEDURE ON (B)(6) 2010. THE PHYSICIAN WAS IN TRAINING TO THE USE OF THE MYNX AND USED THE DEVICE FOR FEMORAL ARTERY CLOSURE FOLLOWING THE PROCEDURE. THE ACI SALES PROFESSIONAL WAS PRESENT. THE GROIN SHOT REVEALED NO ABNORMALITIES, PVD OR CALCIUM AND THE STICK LOCATION WAS REPORTEDLY GOOD. THERE WAS NO FURTHER INFORMATION PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX. IT WAS REPORTED THAT APPROXIMATELY 30 DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF FOOT PAIN. THE PATIENT WAS REFERRED TO A RADIOLOGIST WHO ASSESSED THAT THERE WAS SEALANT IN THE ARTERY CAUSING AN OCCLUSION. A PERCUTANEOUS INTERVENTION WAS SUCCESSFULLY PERFORMED, HOWEVER NO MATERIAL WAS SENT TO PATHOLOGY TO CONFIRM THE CONTENTS OF THE OCCLUSION. NO FURTHER INFORMATION WAS PROVIDED.

    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