BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 24865968 · Received April 13, 2026

    Report

    Report Number
    3004939290-2026-00432
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 18, 2026
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE POLYETHYLENE GLYCOL (PEG) SEALANT OF A 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS OBSERVED PROTRUDING AT THE LEFT AND RIGHT ACCESS SITES IN A THIN PATIENT. THE ATTENDING WAS ADVISED TO HYDRATE WITH SALINE AND TRIM THE PEG AT THE SKIN LEVEL, AND DERMABOND WAS APPLIED. THE PATIENT REPORTED GROIN PAIN WITH SLIGHT REDNESS AT THE SITE AND NO VISIBLE INFECTION. FOUR DEVICES WERE USED, WITH ONE ON THE LEFT AND THREE ON THE RIGHT. TWO DEVICES ON THE RIGHT WERE DEPLOYED COMPLETELY WITHIN THE SKIN TRACT, WHILE ONE ON THE LEFT AND ONE ON THE RIGHT HAD SEALANT PARTIALLY PROTRUDING FROM THE SKIN. A SHALLOW VESSEL DEPTH WAS NOTED. THE SEALANT WAS NOT DISLODGED FROM THE ARTERIOTOMY AND DID NOT STICK TO THE DEVICE. NO RESISTANCE WAS NOTED DURING USE, AND ALL DEPLOYMENT STEPS INCLUDING BUTTON ACTIVATIONS AND BALLOON DEFLATION WERE COMPLETED AS INTENDED. THE DEVICE WAS STORED BELOW 25 °C AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO DAMAGE NOTED PRIOR TO USE. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA IN AN INPATIENT SETTING WITH SAME-DAY DISCHARGE. POST-PROCEDURE CARE INCLUDED DERMABOND AND A HEMOSTATIC BANDAGE, AND COUNTER PRESSURE WAS APPLIED FOR APPROXIMATELY FIVE MINUTES TO ACHIEVE HEMOSTASIS. AN 8 AND 10 FRENCH FAST-CATH SHEATH FROM A NON-CORDIS MANUFACTURER WAS USED. THE VESSEL DIAMETER WAS CONFIRMED TO BE AT LEAST 5 MM. THE PATIENT RECEIVED PAIN MEDICATION AND ANTIBIOTICS, AND NO INFECTION OR ONGOING COMPLICATIONS WERE REPORTED ONE-WEEK POST-PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT HAD BEEN PICKING AT THE SEALANT PROTRUDING FROM THE ACCESS SITES. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186356 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female FINAL ACT: 419| PROTAMINE GIVEN: 30 MG