BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1984211 · Received February 10, 2011

    Report

    Report Number
    3004939290-2011-00011
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 17, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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, THE CAUSE OF THE REPORTED EVENT COULD NOT BE 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)(6) 2011 THAT A (B)(6) FEMALE PATIENT WITH A HISTORY OF HYPERTENSION, DIABETES AND END-STAGE RENAL DISEASE UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2011. IT WAS REPORTED THAT THE PROCEDURE WENT WELL WITH NO REPORTED COMPLICATIONS. FOLLOWING THE PROCEDURE, MYNX WAS USED FOR FEMORAL ARTERY CLOSURE. THE RADIOLOGY TECHNOLOGIST WHO DEPLOYED THE DEVICE WAS IN TRAINING TO THE DEVICE. THERE WERE NO REPORTED COMPLICATIONS DURING THE MYNX CLOSURE AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. SOMETIME POST PROCEDURE (EXACT TIMEFRAME UNKNOWN), THE PATIENT UNDERWENT DIALYSIS. IT WAS REPORTED THAT POST DIALYSIS, THE ACCESS SITE WAS STABLE. THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY. THE FOLLOWING MORNING (B)(6) 2011 THE PATIENT COMPLAINED OF LEG PAIN AND SWELLING IN THE RIGHT GROIN. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2011 WHERE A HEMATOMA (22CM X 20CM) WAS NOTED. IT WAS ALSO REPORTED THAT THE PATIENT'S HEMOGLOBIN HAD DROPPED FROM 13 TO 7.5 G/DL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS RECOMMENDED FOR SURGICAL INTERVENTION. ON (B)(6) 2011, THE PATIENT UNDERWENT A SURGICAL INTERVENTION INCLUDING INCISION AND DRAINAGE (I & D) AND REPAIR OF THE RIGHT FEMORAL ARTERY PER OPERATIVE NOTES AS REVIEWED BY THE ACI SALES PROFESSIONAL. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED. 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 79 YR Required Intervention