BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 3911299 · Received July 2, 2014

    Report

    Report Number
    3004939290-2014-00080
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.THE REVIEW OF THE LHR (LOT F1410701) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2014. ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY VIA A 6F TERUMO SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE 6.5 MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS TRAINING TO THE ACI DEVICE, SELECTED A MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. ON (B)(6) 2014, THE DEPLOYING PHYSICIAN CONTACTED THE SALES REPRESENTATIVE AND STATED THAT ON (B)(6) 2014 THE PATIENT HAD PRESENTED TO THE ER OF ANOTHER HOSPITAL WITH AN OOZE AND A HEMATOMA. AN ULTRASOUND WAS PERFORMED AND A 2 CM HEMATOMA WAS FOUND. THE RADIOLOGIST READ THE ULTRASOUND AS A FEMORAL VEIN THROMBOSIS. THE RADIOLOGIST MISTAKENLY VIEWED THE MYNX SEALANT, SUPERIMPOSED OVER THE FEMORAL VEIN AS VENOUS THROMBOSIS. THE PATIENT WAS STARTED ON LOVENOX WHICH MADE THE HEMATOMA A "LITTLE" WORSE. THE DEPLOYING PHYSICIAN WAS NOTIFIED AFTERWARDS AND ORDERED THE STAFF TO STOP THE LOVENOX AND ORDERED A CT ANGIOGRAPHY, AND DETERMINED THERE WAS NO VENOUS THROMBOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. AS OF (B)(6) 2014, THE PATIENT WAS REPORTED TO BE DOING FINE. THE PATIENT'S HOSPITALIZATION WAS DUE TO THE HEMATOMA. NOTE: THE DEPLOYING PHYSICIAN REPORTED THAT THE DAY OF THE CATHETERIZATION PROCEDURE, THE PATIENT WAS EXTREMELY NONCOMPLIANT AND CHECKED OUT OF THE CATH LAB BEFORE THE DISCHARGE TIME. THE PHYSICIAN BELIEVES THE EVENT WAS SIMPLY A HEMATOMA THAT WAS INCREASED BY LOVENOX USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385639 MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6740 F1410701

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| O LOVENOX