BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP (5F) VASCULAR CLOSURE DEVICE

    MDR report key: 4233394 · Received November 6, 2014

    Report

    Report Number
    3004939290-2014-00731
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS ENGAGED TO THE HANDLE WITH THE PROCEDURAL SHEATH PULLED BACK AGAINST THE SHUTTLE. THE DEVICE WAS RECEIVED WITH THE LUER-LOCK FITTING OF THE SYRINGE FRACTURED AND TWO PIECES OF MATERIAL BROKEN OFF. A NEW SYRINGE WAS USED TO INFLATE THE BALLOON, PRESSURE WAS MAINTAINED AND THE DEVICE PERFORMED AS INTENDED. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE BROKEN SYRINGE COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1423103) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: POSSIBLE FAILURE TO DEPLOY, NOT COMPLETELY CLEAR, MANUAL COMPRESSION WAS APPLIED FOR 30 MINUTES OR LESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. PROCEDURE TYPE: DIAGNOSTIC SHEATH SIZE: 5F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713429 MYNXGRIP (5F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX5021 F1423103

    Patients

    Seq Age Sex Outcome Treatment
    1