BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1821456 · Received August 31, 2010

    Report

    Report Number
    3004939290-2010-00106
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 23, 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 INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE CAUSE OF THE REPORTED HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT HEMOSTASIS WAS SUCCESSFULLY ACHIEVED, THEREFORE, THERE IS NO INDICATION OR EVIDENCE TO SUGGEST THAT THE DEVICE DID NOT PERFORM AS INTENDED. ADDITIONALLY, THERE WAS NO INFORMATION PROVIDED REGARDING THE PRE-PROCEDURAL FEMORAL ANGIOGRAM TO ASSESS SUITABILITY OF CLOSURE. ALSO, HEMATOMAS ARE ANTICIPATED COMPLICATIONS OF CATHETERIZATION PROCEDURES, REGARDLESS OF THE USE OF CLOSURE DEVICES. THEY CAN ALSO OCCUR WITH MANUAL COMPRESSION. 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

    A MALE PATIENT WITH NO KNOWN CO-MORBIDITIES UNDERWENT A CORONARY DIAGNOSTIC PROCEDURE ON (B)(6) 2010 VIA A 6F PROCEDURAL SHEATH. NO PERI-PROCEDURAL ANTICOAGULATION WAS ADMINISTERED. FOLLOWING THE PROCEDURE, THE MYNX DEVICE WAS CHOSEN FOR FEMORAL ARTERY CLOSURE AND DEPLOYED BY A TECHNICIAN TRAINED TO THE MYNX. THERE WAS NO REPORTED DIFFICULTY DURING DEPLOYMENT AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS TRANSFERRED TO THE HOLDING AREA, AND APPROXIMATELY 1 HOUR LATER A HEMATOMA DEVELOPED. THE HEMATOMA WAS DESCRIBED AS "FOOTBALL-SIZED". THERE WAS NO REPORTED DROP IN BLOOD PRESSURE, HOWEVER DUE TO THE SIZE OF THE HEMATOMA WHICH WAS REPORTEDLY "HARD TO CONTROL", THE PATIENT WAS SENT TO SURGERY FOR SUCCESSFUL HEMATOMA EVACUATION (APPROXIMATELY 450 CC). THERE WAS NO REPORTED BLOOD TRANSFUSION OR ADDITIONAL TREATMENT OR INTERVENTION REPORTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 WITHOUT 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