BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1904514 · Received November 22, 2010

    Report

    Report Number
    3004939290-2010-00124
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 LIMITED PATIENT AND PROCEDURAL INFORMATION PROVIDED, IT IS INCONCLUSIVE AS TO THE CAUSE OF THE REPORTED RETROPERITONEAL HEMATOMA. THERE WAS NO INFORMATION PROVIDED REGARDING ANY RELEVANT PATIENT CO-MORBIDITIES OR EXISTING MEDICATIONS. ADDITIONALLY, NO INFORMATION WAS PROVIDED REGARDING THE PROCEDURAL DETAILS OR FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE. 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 THE ACI SALES PROFESSIONAL THAT FOLLOWING A CATHETERIZATION PROCEDURE (TYPE UNKNOWN), MYNX WAS USED FOR FEMORAL ARTERY CLOSURE. AN ANGIOGRAM WAS TAKEN OF THE ILIACS PRIOR TO THE MYNX PROCEDURE, HOWEVER, THE COMMON FEMORAL ARTERY AND SHEATH INSERTION SITE WERE NOT VISUALIZED TO ASSESS SUITABILITY OF CLOSURE. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AND DEPLOYED PER THE INSTRUCTIONS FOR USE BY A TRAINED USER. THERE WERE NO REPORTED ISSUES WITH THE MYNX DEPLOYMENT OR ACUTE HEMOSTASIS. IT WAS REPORTED THAT WHILE IN HOLDING, THE PATIENT DEVELOPED A RETROPERITONEAL HEMATOMA (RPH). ANY SYMPTOMS (SUCH AS HYPOTENSION OR ABDOMINAL/FLANK PAIN) WERE NOT REPORTED AND THEREFORE IT IS ALSO UNKNOWN HOW THE RPH WAS DISCOVERED. THE RPH WAS CONFIRMED VIA A CT SCAN AND THE PATIENT UNDERWENT A TRANSFUSION (NUMBER OF UNITS UNKNOWN). THE PATIENT IS REPORTEDLY DOING FINE, WITH NO REPORTS OF FURTHER CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention