BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1880131 · Received October 22, 2010

    Report

    Report Number
    3004939290-2010-00113
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED PROCEDURE AND PATIENT INFORMATION PROVIDED, THE CAUSE OF THE REPORTED LOCAL REACTION COULD NOT BE CONCLUSIVELY DETERMINED. THERE WAS NO INFORMATION PROVIDED REGARDING THE PRE-PROCEDURAL FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE, OR ANY INFORMATION PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX AND ITS USE PER THE INSTRUCTIONS FOR USE (IFU). IN ADDITION, THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION. ADDITIONALLY, THE MYNX IS TERMINALLY STERILIZED AND SUBJECTED TO LAL (LIMULUS AMEBOCYTE LYSATE) TESTING TO ENSURE THE PRODUCT MEETS STERILIZATION AND BACTERIAL ENDOTOXIN REQUIREMENTS PRIOR TO EACH LOT BEING RELEASED FOR COMMERCIAL USE. ADDITIONALLY THE IFU STATES: THE FOLLOWING ADVERSE REACTIONS OR CONDITIONS MAY ALSO BE ASSOCIATED WITH MYNX OR WITH THE DIAGNOSTIC OR INTERVENTIONAL PROCEDURE: ALLERGIC REACTION, FOREIGN BODY REACTION, INFECTION, INFLAMMATION, OR VESSEL LACERATION. 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 BY RISK MANAGEMENT AT THE USER FACILITY THAT A PATIENT UNDERWENT A HEART CATHETERIZATION PROCEDURE ON (B)(6) 2010. THERE WAS NO INFORMATION PROVIDED REGARDING THE PRE-PROCEDURAL FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE, OR ANY INFORMATION PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX AND ITS USE PER THE INSTRUCTIONS FOR USE. IT WAS REPORTED THAT 7 DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF SWELLING AND REDNESS AT THE GROIN. IT WAS REPORTED THAT AN INCISION AND DRAINAGE (I & D) AND DEBRIDEMENT OF THE RIGHT GROIN WAS PERFORMED IN THE OPERATING ROOM. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRAVENOUS ANTIBIOTICS