BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2032858 · Received March 29, 2011

    Report

    Report Number
    3004939290-2011-00035
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1034108) DID NOT EXHIBIT ANY ISSUE THAT SUGGESTS THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2011. A 6F PROCEDURAL SHEATH WAS USED TO OBTAIN ACCESS AT THE RIGHT COMMON FEMORAL ARTERY (CFA) AT THE TOP OF THE FEMORAL HEAD ABOVE THE BIFURCATION, YET BELOW THE INFERIOR EPIGASTRIC ARTERY. A PRE-PROCEDURAL FEMORAL ANGIOGRAM WAS TAKEN AND SHOWED NO SIGNIFICANT DISEASE PRESENT AT THE ACCESS SITE. THE BALLOON WAS NOT PREPPED WITH 50/50 CONTRAST AND SALINE MIXTURE. FOLLOWING THE PROCEDURE, THE RADIOLOGY TECHNOLOGIST (RT) WHO IS TRAINED TO THE MYNX PROCEDURE, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT THE DEVICE PREPARATION AND THE DEPLOYMENT STEPS WERE PER THE MYNX INSTRUCTIONS FOR USE (IFU). HEMOSTASIS WAS SUCCESSFULLY ACHIEVED AFTER THE STANDARD FINGERTIP COMPRESSION. THERE WAS NO REPORT OF COMPLICATION DURING THE PROCEDURE NOR THE CLOSURE. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THAT SAME DAY. THREE DAYS POST PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL EMERGENCY ROOM (ER) COMPLAINING OF PAIN IN HIS RIGHT LEG AND FOOT. THE LEFT COMMON FEMORAL ARTERY (CFA) WAS ACCESSED AND A PERIPHERAL ANGIOGRAM WAS TAKEN WHICH REVEALED AN OCCLUSION AT THE RIGHT ANTERIOR TIBIAL (AT) AND A TWO VESSEL RUN-OFF WAS NOTED AT THE RIGHT FOOT. THE PHYSICIAN PERFORMED A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ON THE RIGHT AT AND A PRONTO EXTRACTION CATHETER WAS ALSO USED TO ASPIRATE THE THROMBUS FROM THE AT. THE PATIENT WAS PUT ON TISSUE PLASMINOGEN ACTIVATOR (TPA ) OVERNIGHT. THE FOLLOWING DAY, THE RIGHT AT SHOWED IMPROVEMENT YET THE PHYSICIAN FELT THAT AN ADDITIONAL STENT IMPLANTATION WAS NEEDED TO RESTORE ADEQUATE FLOW. THE RIGHT AT WAS IMPLANTED WITH A STENT AND AN IMPROVED FLOW WAS NOTED. THE FOLLOWING DAY ((B)(6) 2011) THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME WITHOUT CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1034108

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R