BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 3942544 · Received July 17, 2014

    Report

    Report Number
    3004939290-2014-00098
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE NEW INFORMATION RECEIVED, ADVERSE EVENT IS BEING REMOVED. BASED ON THE NEW INFORMATION RECEIVED, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) IS BEING REMOVED. BASED ON THE NEW INFORMATION RECEIVED ACCESSCLOSURE, INC. DOES NOT CONSIDER THE EVENT TO BE FDA REPORTABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE ACI DISTRIBUTOR REPORTED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE. THE STICK LOCATION WAS AT THE COMMON FEMORAL ARTERY. A PRE-PROCEDURE FEMORAL ANGIOGRAM WAS PERFORMED WHICH SHOWED PRESENCE OF PVD AND THE VESSEL SIZE TO BE >5 MM. THE HEMATOMA WAS NOTED TO BE <6 CM IN SIZE. MANUAL COMPRESSION WAS APPLIED FOR 15 MINUTES. IT WAS REPORTED THAT THE DEVICE PLUG (SEALANT) FAILED TO ADHERE TO THE VESSEL. AN ULTRASOUND WAS PERFORMED AFTER THE DEVICE DEPLOYMENT WHICH DEMONSTRATED THAT THE PLUG WAS WELL AWAY FROM THE VESSEL WALL AND IN THE SUBCUTANEOUS FAT. THE PATIENT WAS NOT HOSPITALIZED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: THE PHYSICIAN NOTED A SMALL HEMATOMA FOLLOWING A MYNXGRIP DEPLOYMENT, REQUIRING A FEW MINUTES OF ADJUNCTIVE COMPRESSION. NO SALES REPRESENTATIVE WAS PRESENT DURING THIS CASE. THE HEMATOMA OCCURRED DURING THE WEEK OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418623 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other