BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1954437 · Received January 10, 2011

    Report

    Report Number
    3004939290-2011-00005
    Event Type
    Injury
    Date Received
    January 10, 2011
    Report Date
    December 22, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 WITHOUT THE DEVICE FOR INVESTIGATION, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED. NO PATHOLOGY OR ANALYSIS REPORTS SPECIFIC TO THIS EVENT WERE AVAILABLE AT THE TIME OF THIS INVESTIGATION. 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 BY THE ACI SALES PROFESSIONAL THAT A FEMALE PATIENT IN HER (B)(6)UNDERWENT A CAROTID INTERVENTION (EXACT DATE UNKNOWN BUT SOMETIME THE WEEK OF (B)(6) 2010). ACCESS WAS OBTAINED VIA A 6F SHEATH AT THE RIGHT GROIN. A FEMORAL ANGIOGRAM REVEALED A HIGH STICK AT THE BIFURCATION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL SIZE WAS SMALL (4-5 MM). THE ACCOUNT IS TRAINED TO USE THE 50/50 CONTRAST AND SALINE MIXTURE BUT DID NOT DO SO IN THIS CASE. FOLLOWING THE PROCEDURE, MYNX WAS USED FOR FEMORAL ARTERY CLOSURE. IT WAS REPORTED THAT THE PHYSICIAN CHECKED THE STOP COCK AND TEMPORARY HEMOSTASIS WAS ACHIEVED. AFTER DEPLOYING THE DEVICE, HOWEVER, IT WAS NOTED THAT HEMOSTASIS WAS NOT ACHIEVED AND THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION. TWO HOURS POST PROCEDURE, THE PATIENT COMPLAINED OF A COLD FOOT. SHE WAS TAKEN BACK TO THE CATH LAB WHERE AN ANGIOGRAM WAS PERFORMED CONTRALATERAL WITH ACCESS AT THE LEFT SIDE VIA A 5F SHEATH. THE ANGIOGRAM REVEALED A FILLING DEFECT DISTAL TO THE ARTERIOTOMY. A VASCULAR SURGEON WAS CONSULTED. IT WAS ASSESSED THAT THE ARTERY WASN'T FULLY OCCLUDED; HOWEVER, A CUT-DOWN WAS PERFORMED AND THE VASCULAR SURGEON REMOVED WHAT WAS ASSESSED AS POLYETHYLENE GLYCOL (PEG). THE PATIENT IS DOING FINE AND REMAINED HOSPITALIZED AT THE TIME OF THIS REPORT. OF NOTE: THE ACCESS SITE AT THE LEFT GROIN WAS REPORTEDLY CLOSED BY "SEWING THE ARTERY SHUT." NO FURTHER INFORMATION WAS PROVIDED.

    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 54 YR Required Intervention