BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 23933316 · Received December 31, 2025

    Report

    Report Number
    3004939290-2025-01192
    Event Type
    Injury
    Date Received
    December 31, 2025
    Report Date
    December 31, 2025
    Manufacturer
    CORDIS US CORP
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, APPROXIMATELY 5-7 DAYS AFTER A PROCEDURE USING THREE 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCD) THE PATIENT PRESENTED WITH A LOCAL REACTION TO THE GROIN WITH DISCHARGE. ALL THREE DEVICES WERE USED ON THE SAME LEG. THE DEVICES WERE USED FOR CLOSURE IN A PULSE SELECT CASE. THERE WAS NO INFECTION INITIALLY SEEN HOWEVER ANTIBIOTICS WERE ADMINISTERED AT THE FOLLOW UP VISIT. THIS WAS CONSIDERED A LOCAL REACTION AS INFECTION WAS NOT CONFIRMED BY CULTURE. THE DEVICE PACKAGING WAS NOT COMPROMISED DURING STORAGE. THE PACKAGE WAS NOT OPENED IN A STERILE FIELD, BUT STERILE TECHNIQUE WAS FOLLOWED. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS PRIOR TO THE PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE ACCESS SITE WAS CLEANED AND MAINTAINED POST PROCEDURE. THE DEVICES WERE NOT RETURNED FOR EVALUATION. A PRODUCT HISTORY RECORD (PHR) COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A LOCAL REACTION AFTER DEPLOYMENT OF THE SEALANT(S) INTO THE TISSUE TRACT OF THE PATIENT IS DEFINED AS A LOCALIZED INFLAMMATION OF THE GROIN TISSUE THAT IS NOT AN INFECTION. THE PATIENT MAY EXPERIENCE ACCESS SITE IRRITATION, REDNESS, RASH, OR INFLAMMATION. LOCAL REACTIONS CAN BE DUE TO THE PATIENT¿S SENSITIVITY TO THE POLYETHYLENE GLYCOL (PEG) SEALANT MATERIAL, OR THE POST-CARE TREATMENT OF THE ACCESS SITE. SOME LOCAL REACTION SYMPTOMS ARE MILD AND RESOLVE ON THEIR OWN, WHILE OTHERS MAY REQUIRE OVER-THE-COUNTER MEDICATIONS, OR, WORST CASE SCENARIO, MEDICAL INTERVENTION. LOCAL REACTIONS RESULTING FROM INVASIVE PROCEDURES ARE A WELL-KNOWN POTENTIAL ADVERSE EVENT AND ARE LISTED IN THE MYNX CONTROL VENOUS INSTRUCTIONS FOR USE (IFU). BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO ACCESS SITE REACTION EXPERIENCED. HOWEVER, PATIENT/PROCEDURAL FACTORS ARE POSSIBLE. THE EVENT OF ¿LOCAL REACTION¿ COULD NOT BE OBSERVED AS AN IMAGE OF THE ACCESS SITE WAS NOT PROVIDED. ACCORDING TO THE PATIENT BROCHURE, WHICH IS NOT INTENDED AS A MITIGATION, THE PUNCTURE SITE POST PROCEDURE CARE INSTRUCTS, ¿RE-APPLY A NEW BAND-AID EVERY DAY OR MORE FREQUENTLY FOR 5 DAYS OR UNTIL A SCAB HAS FORMED AT THE SITE. KEEP THE SITE CLEAN AND DRY. YOU MAY SHOWER 24 HOURS AFTER THE PROCEDURE, AND GENTLY CLEAN PUNCTURE SITE WITH SOAP AND WARM WATER. DO NOT SUBMERGE WOUND UNTIL COMPLETELY CLOSED. AFTER SHOWERING, GENTLY DRY THE SITE BY PATTING WITH A CLEAN TOWEL AND COMPLETELY AIR-DRY BEFORE COVERING WITH A BAND-AID. AVOID TIGHT FITTING CLOTHES OR UNDERWEAR UNTIL THE SITE HAS HEALED.¿ BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION TO SUGGEST THAT THE REPORTED INCIDENT COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5-7DAYS AFTER A PROCEDURE USING THREE 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (VCD) THE PATIENT PRESENTED WITH A LOCAL REACTION TO THE GROIN WITH DISCHARGE. ALL THREE DEVICES WERE USED ON THE SAME LEG. THE DEVICES WERE USED FOR CLOSURE IN A PULSE SELECT CASE. THERE WAS NO INFECTION INITIALLY SEEN HOWEVER ANTIBIOTICS WERE ADMINISTERED AT THE FOLLOW UP VISIT. THIS WAS CONSIDERED A LOCAL REACTION AS INFECTION WAS NOT CONFIRMED BY CULTURE. THE DEVICE PACKAGING WAS NOT COMPROMISED DURING STORAGE. THE PACKAGE WAS NOT OPENED IN A STERILE FIELD, BUT STERILE TECHNIQUE WAS FOLLOWED. THE PATIENT DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS PRIOR TO THE PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE ACCESS SITE WAS CLEANED AND MAINTAINED POST PROCEDURE. THE DEVICES ARE NOT BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2792639 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.