BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1951696 · Received January 6, 2011

    Report

    Report Number
    3004939290-2011-00002
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED SEALANT MISDEPLOYMENT AND OCCLUSION COULD NOT BE CONCLUSIVELY DETERMINED. THE PHYSICIAN ASSESSED THE OCCLUSION TO HAVE BEEN CAUSED BY WHAT WAS BELIEVED TO BE SEALANT, HOWEVER, WITHOUT SOURCE DOCUMENTS OR THE MATERIAL TO PERFORM CHEMICAL ANALYSIS OF THE COMPOSITION THIS COULD NOT BE CONFIRMED. ADDITIONALLY, BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE MATERIAL WAS SENT TO PATHOLOGY. 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 (B)(6) FEMALE PATIENT UNDERWENT A DIAGNOSTIC HEART CATHETERIZATION PROCEDURE ON (B)(6) 2010 BY A PHYSICIAN. ACCESS WAS OBTAINED VIA A 6F PROCEDURAL SHEATH AT THE LEFT COMMON FEMORAL ARTERY (CFA). FOLLOWING THE PROCEDURE, A PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE FOR FEMORAL ARTERIAL CLOSURE. A PRE-PROCEDURAL FEMORAL ANGIOGRAM OF THE RIGHT FEMORAL WAS OBTAINED AND SHOWED A NOMINAL AMOUNT OF CALCIUM/PVD PRESENT. A 50/50 CONTRAST-SALINE MIXTURE WAS USED TO VISUALIZE THE DEPLOYMENT OF THE MYNX. IT WAS REPORTED THAT AS THE PHYSICIAN BEGAN TO LOCATE THE ARTERIOTOMY WITH THE MYNX BALLOON, HE OPENED THE SIDE PORT OF THE SHEATH TO CONFIRM TEMPORARY HEMOSTASIS WITH THE MYNX. HEMOSTASIS HAD NOT BEEN ACHIEVED SO HE THEN APPLIED MORE TENSION ON THE DEVICE AND DEPLOYED THE SEALANT. THE DEVICE WAS REMOVED PER IFU AND THERE WAS NO EVIDENCE OF ANY COMPLICATION AT THE ACCESS SITE. THE CATH LAB STAFF BEGAN THEIR POST-CARE ASSESSMENT AND FOUND THAT THE PEDAL PULSES IN THE PATIENT'S RIGHT FOOT HAD DIMINISHED. THE PHYSICIAN THEN INSTRUCTED THE STAFF TO PREP THE PATIENT'S LEFT GROIN TO ACCESS THE ARTERY. THE PHYSICIAN THEN PERFORMED AN ANGIOGRAM AT THE RIGHT CFA. THE ANGIOGRAM REVEALED A FLOW-LIMITING AREA OF WHAT WAS THOUGHT TO BE SEALANT. A VASCULAR SURGEON WAS CONSULTED AND CONFIRMED THAT THE PATIENT NEEDED TO UNDERGO A SURGICAL PROCEDURE TO REMOVE THE ALLEGED SEALANT. THE PATIENT WAS ADMINISTERED 5000 UNITS OF HEPARIN. THE VASCULAR SURGEON PERFORMED A CUT DOWN AND REPORTEDLY DID NOT HAVE TO DISSECT DEEP INTO THE ARTERY AS THE SEALANT WAS ASSESSED TO BE PARTIALLY INTRAVASCULAR AND PARTIALLY EXTRAVASCULAR. HE REMOVED THE ALLEGED SEALANT FROM THE SUBCUTANEOUS TISSUE. REPORTEDLY, THE PATIENT'S DISTAL PULSES WERE RESTORED. THERE WAS NO HEMATOMA OR SWELLING NOTED AND THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT FURTHER COMPLICATION OR CLINICAL SEQUELA.

    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, 5000 UNITS