BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2022678 · Received March 17, 2011

    Report

    Report Number
    3004939290-2011-00029
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ACCESSCLOSURE, INC
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IT WAS REPORTED THAT HEPARIN AND A BOLUS OF INTEGRILIN WERE ADMINISTERED PERI-PROCEDURE. INTEGRILIN (EPTIFIBATIDE) IS AN ANTIPLATELET DRUG OF THE GLYCOPROTEIN IIB/IIIA INHIBITOR CLASS. PER THE MYNX INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF MYNX HAVE NOT BEEN ESTABLISHED IN PATIENTS RECEIVING GLYCOPROTEIN IIB/IIIA PLATELET INHIBITORS. 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) 2011 THAT A MALE PATIENT (B)(6) UNDERWENT A CORONARY INTERVENTION CATHETERIZATION PROCEDURE ON (B)(6) 2011. THERE WAS NO INFORMATION PROVIDED REGARDING A PRE-PROCEDURAL FEMORAL ANGIOGRAM TO ASSESS SUITABILITY FOR CLOSURE. ACCESS WAS OBTAINED VIA A 6F CORDIS SHEATH. THE STICK LOCATION WAS AT THE BIFURCATION. HEPARIN AND A BOLUS OF INTEGRILIN WERE ON BOARD. THE PHYSICIAN DID NOT USE 50/50 CONTRAST AND SALINE SOLUTION WHEN PREPPING THE BALLOON. THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE OR THE MYNX DEPLOYMENT. HEMOSTASIS WAS REPORTEDLY ACHIEVED WITH THE MYNX DEVICE. IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT RETURNED TO THE DOCTOR'S OFFICE WHERE A DOPPLER ULTRASOUND WAS PERFORMED THAT DETECTED A PSEUDOANEURYSM (PSA). REPORTEDLY, THE PATIENT WAS TAKEN TO VASCULAR SURGERY WHERE A THROMBIN INJECTION WAS GIVEN. POST THROMBIN INJECTION, THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL (EXACT DATE IS UNKNOWN). NO FURTHER INFORMATION COULD BE OBTAINED.

    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 HEPARIN| BOLUS OF INTEGRILIN