BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 25151017 · Received May 12, 2026

    Report

    Report Number
    3004939290-2026-00566
    Event Type
    Injury
    Date Received
    May 12, 2026
    Report Date
    May 20, 2026
    Manufacturer
    CORDIS US CORP
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, A CUSTOMER STATED THAT 2-DAYS POST DEPLOYMENT OF A MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD), THE PATIENT WAS DIAGNOSED WITH A SMALL PULMONARY EMBOLISM. THE PHYSICIAN BELIEVED THE PULMONARY EMBOLISM WAS RELATED TO THE MYNX VASCULAR CLOSURE DEVICE. THE DEVICE WAS USED IN A CARDIAC ABLATION PROCEDURE WITH AN ANTEGRADE APPROACH, AND THE DEPLOYER WAS MYNX CERTIFIED. A CORDIS SHEATH INTRODUCER WAS USED, UNKNOWN IF 8 OR 10F IN SIZE. VESSEL SUITABILITY WAS VERIFIED ON VENOGRAPHY, INCLUDING APPROPRIATE INSERTION ANGLE, VESSEL DIAMETER WAS CONFIRMED TO BE =5 MM, AND NO VESSEL TORTUOSITY WAS REPORTED. MANUAL PRESSURE WAS APPLIED FOR 3¿10 MINUTES FOLLOWING CLOSURE, AND NO COMPRESSION DEVICES OR DRESSINGS WERE USED. THE PATIENT REMAINED ON BED REST FOR 2 HOURS FLAT, 2 HOURS UPRIGHT, AND 1 HOUR MOBILE. THE PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION AND WAS RECEIVING ANTICOAGULANT, ANTIPLATELET, OR THROMBOLYTIC THERAPY. THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207947 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.