BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 4192498 · Received October 22, 2014

    Report

    Report Number
    3004939290-2014-00607
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION WAS NOT PERFORMED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REVIEW OF THE LHR (LOT F1419201) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE ACI SALES PROFESSIONAL REPORTED THE FOLLOWING INFORMATION: THE PHYSICIAN DEPLOYED THE DEVICE PERFECTLY IN THE PATIENT WHO HAD AN INTERVENTION DONE. THE STAFF CLAIMED THAT IT WAS NOTED AFTER THE DEPLOYMENT THAT THE PATIENT HAD A HEMATOMA (SIZE UNKNOWN) TO THE RIGHT SIDE OF THE PATIENT'S BODY ALMOST ON THE HIP. IT IS UNCERTAIN AT WHAT POINT THE HEMATOMA DEVELOPED. A FEMOSTOP WAS APPLIED AND LATER THAT EVENING A SURGICAL STITCH WAS APPLIED TO THE PUNCTURE SITE. THE VASCULAR SURGEON THAT DID THE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) OF THE LOWER EXTREMITIES ALSO DID THE SURGICAL SUTURE REPAIR. THE ANGIO PROCEDURE WENT WELL. THE PATIENT'S BLOOD PRESSURE WAS NOTED AS "NORMAL" BUT THE PATIENT WAS ON TPA THE DAY BEFORE TO UNCLOG A LOWER EXTREMITY VESSEL. PROCEDURE TYPE: INTERVENTION PERIPHERAL STICK LOCATION: MEDIUM SHEATH SIZE: 7F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672722 MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6740 F1419201

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention