BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1578969 · Received January 13, 2010

    Report

    Report Number
    3004939290-2010-00007
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 14, 2009
    Report Date
    December 15, 2009
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED; HOWEVER, A SUBSTANCE THOUGHT TO BE THE SEALANT WAS RETURNED. VISUAL EXAMINATION OF THE RETURNED SUBSTANCE SHOWED IT WAS MOST LIKELY A SEALANT. BASED ON THE INFO PROVIDED, THE CAUSE OF THE REPORTED LOCAL REACTION AND THE SEALANT EXPULSION COULDN NOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER INSTRUCTIONS FOR USE (IFU). THE MYNX IS TERMINALLY STERILIZED AND SUBJECTED TO LAL (LIMULUS AMEBOCYTE LYSATE) TESTING TO ENSURE THE PRODUCT MEETS STERILIZATION AND BACTERIAL ENDOTOXIN REQUIREMENTS, PRIOR TO EACH LOT BEING RELEASED FOR COMMERCIAL USE. ADDITIONALLY THE IFU STATES: THE FOLLOWING ADVERSE REACTIONS OR CONDITIONS MAY ALSO BE ASSOCIATED WITH MYNX OR WITH THE DIAGNOSTIC OR INTERVENTIONAL PROCEDURE: ALLERGIC REACTION, FOREIGN BODY REACTION, INFECTION, INFLAMMATION, OR VESSEL LACERATION. 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 AN ACI SALES PROFESSIONAL THAT A MALE PT UNDERWENT A CHEMO EMBOLIZATION PROCEDURE IN 2009. THE MYNX DEPLOYER WAS A RADIOLOGY TECHNICIAN, TRAINED TO THE USE OF THE MYNX. SHE PROCEEDED TO PREP AND DEPLOY THE DEVICE PER THE INSTRUCTIONS FOR USE. THE ACI SALES PROFESSIONAL WAS IN ATTENDANCE AND REPORTED THAT THE DEPLOYMENT WAS UNEVENTFUL AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PT WAS IN THE HOSPITAL FOR A NUMBER OF REASONS INCLUDING GALL BLADDER SURGERY. SIX DAYS LATER, THE PT PRESENTED TO THE HOSPITAL WITH A FEVER AND WAS RE-ADMITTED. THE FOLLOWING DAY THE ACCESS SITE WAS RED, INFLAMED AND PUS WAS PRESENT. WHEN THE PHYSICIAN'S ASSISTANT PALPATED THE GROIN, A FOREIGN SUBSTANCE POPPED OUT. THE SUBSTANCE WAS GIVEN TO THE ACI SALES PROFESSIONAL WHO VISUALLY CONFIRMED IT WAS THE MYNX SEALANT THAT WAS STILL IN ITS ORIGINAL SHAPE. THE PT WAS PLACED ON IV ANTIBIOTICS AND REMAINED IN THE HOSPITAL FOR 3 DAYS. THE PT WAS DISCHARGED WITH NO FURTHER CLINICAL SEQUELAE AND IS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R