BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 928190 · Received October 17, 2007

    Report

    Report Number
    3004939290-2007-00012
    Event Type
    Injury
    Date Received
    October 17, 2007
    Date of Event
    September 20, 2007
    Report Date
    October 17, 2007
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. THERE IS NO EVIDENCE THAT INDICATES THE DEVICE DID NOT MEET SPECIFICATION AND THAT IT DID NOT PERFORM IN ACCORDANCE WITH ITS SPECIFICATIONS AND THE IFU. A CAUSAL ROLE FOR MYNX IN THIS CASE WAS NOT APPARENT GIVEN THAT THE DEVICE FUNCTIONED AS EXPECTED HAVING ACHIEVED HEMOSTASIS WITHOUT IMMEDIATE COMPLICATIONS. THE ETIOLOGY FOR PSEUDOANEURYSM WAS NOT CLEAR GIVEN THAT VESSEL WALL DISRUPTION MAY HAVE OCCURRED WITH ANY COMBINATION OF THE INITIAL STICK, PLACEMENT, REMOVAL, OR MANIPULATION OF THE PROCEDURAL CATHETER, AND/OR PLACEMENT OF THE MYNX CATHETER AND/OR BALLOON FOR EXTRAVASCULAR SEALANT PLACEMENT.

    Description of Event or Problem · 1

    A FEMALE WITH ATYPICAL ANGINA S/P RCA STENT UNDERWENT AN UNCOMPLICATED CORONARY DIAGNOSTIC PROCEDURE IN 2007. PATIENT HAS HISTORY OF 1 PREVIOUS CATH COMPLICATED BY RIGHT CFA PSEUDOANEURYSM. (CLOSURE METHOD AND TREATMENT REQUESTED). PRE-MYNX PROCEDURE, THE PHYSICIAN FELT THAT THE ENTRY SITE WAS ABOVE THE BIFURCATION IN THE CFA AND SUITABLE FOR CLOSURE. THE MYNX DEVICE WAS REPORTEDLY PREPPED AND SUCCESSFULLY DEPLOYED ACCORDING TO IFU. HEMOSTASIS WAS ACHIEVED WITH NO IMMEDIATE COMPLICATIONS. PATIENT WAS AMBULATED AND DISCHARGED PER STANDARD PROCEDURE. THREE DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF LEFT GROIN PAIN WITH ULTRASONIC DOCUMENTATION OF PSEUDOANEURYSM. PATIENT WAS SENT TO SURGERY, WHICH INCLUDED EVACUATION OF A HEMATOMA IN THE SPACE ABOVE THE FEMORAL SHEATH (VISUALIZATION OF THE MYNX SEALANT WAS NOT REPORTED). THE CFA PUNCTURE SITE WAS ISOLATED AND REPAIRED WITH A PROLENE SUTURE. A DRAIN WAS THEN PLACED WITHIN THE WOUND, AND THE WOUND WAS CLOSED. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. NO FURTHER FOLLOW-UP INFO INCLUDING DATE OF DISCHARGE WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R PRE-PROCEDURE MEDS:| LOPRESSOR| VALIUM| VERSED| PERI-PROCEDURE:| LIDOCAINE| ASA