BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 4123754 · Received September 26, 2014

    Report

    Report Number
    3004939290-2014-00598
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. NOTE: UDI NUMBER IS UNKNOWN AS THE MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED BY THE INITIAL REPORTER.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: "I AM A CLINICIAN AND I AM WRITING REGARDING A PATIENT WHO UNDERWENT A PROCEDURE USING A COMMON FEMORAL ACCESS AND A 6F SHEATH, AND CLOSURE WAS ATTEMPTED BY A VERY EXPERIENCED PRACTITIONER USING THE MYNX SYSTEM. THIS WAS UNSUCCESSFUL AND MANUAL PRESSURE WAS THEN APPLIED TO ACHIEVE HEMOSTASIS. UNFORTUNATELY THE PATIENT DEVELOPED A COLD PAINFUL LEG A FEW HOURS LATER, AND SURGICAL EXPLORATION FOUND INTRAVASCULAR PEG MATERIAL OCCLUDING HER VESSELS". THE ACI DISTRIBUTOR MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE EVENT BUT THE ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602650 UNKNOWN MGB MGB ACCESSCLOSURE, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R