BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MYNX

    MDR report key: 7984131 · Received October 19, 2018

    Report

    Report Number
    3004939290-2018-00810
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    April 13, 2018
    Report Date
    October 19, 2018
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY LAUREN ET AL., (APRIL 13, 2018), SAFETY AND EFFICACY OF ARTERIAL CLOSURE DEVICES IN AN OFFICE-BASED ANGIOSUITE, ANN VASC SURG 2018; 51: 10¿17, REPORT 36 DEVICE FAILURES FOR MYNX. DEVICE FAILURE WAS DEFINED AS ANY PARTIAL OR COMPLETE FAILURE OF THE ARTERIAL CLOSURE DEVICE IN ACHIEVING COMPLETE HEMOSTASIS; THE NEED FOR ADDITIONAL CLOSURE ASSISTANCES, SUCH AS AN ADDITIONAL CLOSURE DEVICE, MANUAL COMPRESSION, EXTENDED RECOVERY, OR FEMOSTOP; OR ADMISSION IN CONNECTION WITH THE FEMORAL ACCESS SITE. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. THE REPORTED ¿SEALANT FAILURE TO ACHIEVE HEMOSTASIS¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE FAILURES REPORTED COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW IN THE LITERATURE ARTICLE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. ACCORDING TO THE MYNXGRIP INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, USERS ARE INFORMED TO MAINTAIN FINGERTIP COMPRESSION ON THE SKIN DURING REMOVAL OF THE ADVANCER TUBE FROM THE TISSUE TRACT AND TO CONTINUE TO APPLY FINGERTIP COMPRESSION FOR UP TO 1 MINUTE OR AS NEEDED. IF HEMOSTASIS IS NOT ACHIEVED, THE USER IS INFORMED TO APPLY ADDITIONAL COMPRESSION AS NECESSARY. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    "AS NOTED IN THE PUBLICATION BY LAUREN ET AL., (APRIL 13, 2018). SAFETY AND EFFICACY OF ARTERIAL CLOSURE DEVICES IN AN OFFICE-BASED ANGIOSUITE. ANN VASC SURG 2018; 51: 10¿17, REPORT 36 DEVICE FAILURES FOR MYNX. DEVICE FAILURE WAS DEFINED AS ANY PARTIAL OR COMPLETE FAILURE OF THE ARTERIAL CLOSURE DEVICE IN ACHIEVING COMPLETE HEMOSTASIS; THE NEED FOR ADDITIONAL CLOSURE ASSISTANCES, SUCH AS AN ADDITIONAL CLOSURE DEVICE, MANUAL COMPRESSION, EXTENDED RECOVERY, OR FEMOSTOP; OR ADMISSION IN CONNECTION WITH THE FEMORAL ACCESS SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823692 UNKNOWN MYNX DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNK-MYNX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization