BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2081724 · Received May 9, 2011

    Report

    Report Number
    3004939290-2011-00107
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ACCESSCLOSURE, INC
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND WITH NO RETURNED DEVICE, THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1022905) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL THAT A (B)(6) FEMALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE THE WEEK OF (B)(6) 2011 (EXACT DATE UNKNOWN). ACCESS WAS OBTAINED AT THE RIGHT CFA. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS DURING THE PROCEDURE AND FOLLOWING THE PROCEDURE, THE PHYSICIAN (A TRAINED USER OF THE MYNX DEVICE) CHOSE THE DEVICE FOR FEMORAL ARTERY CLOSURE. THE DEVICE WAS REPORTEDLY PREPPED AND DEPLOYED PER IFU AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE MYNX. THERE WERE NO REPORTED HEMATOMAS OR OTHER COMPLICATIONS FOLLOWING THE CLOSURE. THE PATIENT WAS AMBULATED AND DISCHARGE PER STANDARD HOSPITAL PROTOCOL. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE ER (EMERGENCY ROOM) DEPARTMENT OF THE HOSPITAL WITH SYMPTOMS OF PAIN AND TINGLING IN HER RIGHT LEG. A RUNOFF WAS PERFORMED WHICH DEMONSTRATED A FLOW DISTURBANCE IN THE PATIENT'S LOWER RIGHT LEG. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE A CATHETER WAS USED TO ASPIRATE A SMALL AMOUNT OF MATERIAL AND SENT TO PATHOLOGY. THE RESULTS FROM PATHOLOGY WERE INCONCLUSIVE. THE PATIENT WAS ALSO PUT ON TPA (TISSUE PLASMINOGEN ACTIVATOR) OVERNIGHT. THE FOLLOWING DAY, A PHYSICIAN REPORTEDLY ASPIRATED 40ML OF BLOOD AND MATERIAL USING A CATHETER. THE MATERIAL WAS SENT TO PATHOLOGY AND WAS DIAGNOSED AS A "DISSOLVABLE FOREIGN BODY." A SECOND RUNOFF WAS PERFORMED WHICH "LOOKED BETTER" THAN THE PREVIOUS RUNOFF PERFORMED THE DAY BEFORE. THE PATIENT'S PEDAL PULSES WERE GOOD AND THE PATIENT REPORTED FEELING BETTER AND WITH NO MORE PAIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 WITH NO FURTHER CLINICAL SEQUELA. 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 F1022905

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R