BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1251694 · Received December 2, 2008

    Report

    Report Number
    3004939290-2008-00109
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    October 15, 2008
    Report Date
    December 2, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT AVAILABLE. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED, HOWEVER, THE INSTRUCTIONS FOR USE STATE: MYNX SHOULD ONLY BE USED BY A TRAINED LICENSED PHYSICIAN OR HEALTHCARE PROFESSIONAL. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    A MALE PATIENT, WITH HISTORY OF PVD, UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE IN 2008. THE PROCEDURE WAS PERFORMED VIA A 6 FRENCH PROCEDURAL SHEATH PLACED IN THE RIGHT COMMON FEMORAL ARTERY (CFA). THE UNCOMPLICATED PROCEDURE WAS COMPLETED AND A MYNX VASCULAR CLOSURE DEVICE WAS UTILIZED IN ATTEMPT TO ACHIEVE ACCESS SITE HEMOSTASIS BY AN OPERATOR IN TRAINING TO BECOME CERTIFIED. THE MYNX DEPLOYMENT WAS COMPLETED WITHOUT PERFORMING A PRE-PROCEDURAL FEMORAL ANGIOGRAM (AS PER INSTRUCTIONS FOR USE), AND WITHOUT THE ACCESSCLOSURE REP PRESENT. THE PHYSICIAN DOES NOT RECALL IF THE MYNX DEVICE WAS SUCCESSFULLY DEPLOYED OF IF THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION; HOWEVER, THE PATIENT WAS REPORTEDLY DISCHARGED WITHOUT INCIDENT AND PER HOSPITAL PROTOCOL. THIRTEEN DAYS POST PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF IPSILATERAL LEG PAIN. A PERCUTANEOUS ANGIOGRAM WAS PERFORMED FROM ACCESS GAINED AT THE LEFT CFA. A FLOW DISTURBANCE WAS NOTED AT THE TRIFURCATION OF THE TIBIAL ARTERIES AND THE CATHETERIZATION PROCEDURE WAS COMPLETED WITH MANUAL COMPRESSION APPLIED TO THE LEFT CFA FOR HEMOSTASIS. TPA WAS ADMINISTERED IN ATTEMPT TO RESTORE FLOW AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL (DATE AND CONDITION UNKNOWN). THE FOLLOWING MONTH, THE PATIENT RETURNED DUE TO CONTINUED PAIN IN THE RIGHT LEG. PER THE VASCULAR SURGEON, TWO OF THE THREE ARTERIES AT THE TRIFURCATION WERE CLEAR AND AN EMBOLECTOMY WAS PERFORMED, DUE TO AN OCCLUSION AT THE POSTERIOR TIBIAL ARTERY. FLOW WAS SUCCESSFULLY RESTORED AND THE PATIENT TOLERATED THE PROCEDURE WELL. THERE HAVE BEEN NO ADDITIONAL REPORTS OF CLINICAL SEQUELAE. DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION, NO ADDITIONAL DETAILS OR SOURCE DOCUMENTS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R