BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1821476 · Received August 31, 2010

    Report

    Report Number
    3004939290-2010-00104
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE CAUSE OF THE REPORTED HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT THE PATIENT WAS MORBIDLY OBESE (B)(4). PER THE MYNX INSTRUCTIONS FOR USE (IFU) THE SAFETY AND EFFECTIVENESS OF THE MYNX HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH MORBID OBESITY (BMI > 40 KG/M2). IN ADDITION, HEMATOMAS ARE ANTICIPATED COMPLICATIONS OF CATHETERIZATION PROCEDURES, REGARDLESS OF THE USE OF CLOSURE DEVICES. THEY CAN ALSO OCCUR WITH MANUAL COMPRESSION. THERE IS NO INDICATION THAT THE DEVICE DID NOT MEET SPECIFICATION OR PERFORMED AS INTENDED. 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 TO THE ACI SALES PROFESSIONAL ON (B)(4) 2010 THAT A MORBIDLY OBESE (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2010. ACCESS WAS OBTAINED VIA A 6F SHEATH. A SINGLE, ANTERIOR WALL STICK WAS REPORTED AT THE MIDDLE OF THE FEMORAL HEAD (CFA). THERE WAS NO INFORMATION PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX OR ITS USE PER THE INSTRUCTIONS FOR USE. IT WAS REPORTED THAT 8 HOURS POST-PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA. THE PATIENT WAS SENT TO SURGERY FOR EVACUATION OF THE HEMATOMA. THE PATIENT TOLERATED THE SURGERY WELL AND WAS DISCHARGED WITHOUT FURTHER CLINICAL SEQUELA (EXACT DATE UNKNOWN).

    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