BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2853071 · Received August 24, 2012

    Report

    Report Number
    3004939290-2012-00277
    Event Type
    Injury
    Date Received
    August 24, 2012
    Date of Event
    July 30, 2012
    Report Date
    August 1, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE REVIEW OF THE LHR (LOT F1131101) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY (CFA), VIA A 5F CORDIS SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL APPROXIMATELY 6MM IN SIZE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED WITHOUT ANY ISSUES. THE PATIENT'S GROIN WAS DOCUMENTED AS ASYMPTOMATIC WITH NO HEMATOMA, PAIN OR BRUISING UPON DISCHARGE. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 WITH NO CLINICAL SEQUELA. THE PATIENT RETURNED TO THE EMERGENCY ROOM ON (B)(6) 2012 WITH TENDERNESS, SWELLING AND PAIN IN THE GROIN. A HEMATOMA WAS BELIEVED TO BE PRESENT IN THE RIGHT GROIN. THE PAIN WAS DESCRIBED AS A 4, ON A SCALE OF 1-10. A ULTRASOUND SHOWED A FOCAL PATENT PSA (PSEUDOANEURYSM) IN THE RIGHT GROIN, MEASURING 17MM IN SIZE WITH A PATENT NECK MEASURING 3.7MM, CONNECTING THE PSA WITH THE RIGHT CFA (COMMON FEMORAL ARTERY). ON (B)(6) 2012, THE PHYSICIAN INJECTED THROMBIN WITH GUIDANCE FROM THE ULTRASOUND INTO THE PSA DEMONSTRATING NO FLOW INTO THE PSA. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2012, WITH NO REPORTED CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB ACCESSCLOSURE, INC. MX5001 F1131101

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R