BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 23277411 · Received October 15, 2025

    Report

    Report Number
    3004939290-2025-00842
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 18, 2025
    Manufacturer
    CORDIS US CORP
    Product Code
    MGB
    UDI-DI
    10705032090278
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, A 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) ENCOUNTERED SLIGHT RESISTANCE WHILE PASSING THROUGH AN 8F UNKNOWN SHEATH, POSSIBLY DUE TO A KINK/CREASE. THE DEVICE WAS DELIVERED AND DEPLOYED. DURING REMOVAL, AFTER BUTTON 2 WAS DEPRESSED AND THE DEVICE WAS WITHDRAWN FROM THE PATIENT, THE POLYETHYLENE GLYCOL (PEG) SEALANT WAS FOUND ATTACHED TO THE END OF THE DEVICE. MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT STORED ABOVE 25°CELSIUS. THE DEVICE WAS PREPPED PROPERLY. SLIGHT RESISTANCE WAS ENCOUNTERED DURING SHEATH ENTRY, POSSIBLY INDICATING EXCESS FORCE APPLIED. BOTH BUTTON #1 AND BUTTON #2 WERE FULLY DEPRESSED, AND THE BALLOON WAS FULLY DEFLATED. THE SEALANT APPEARED TO STICK TO THE DEVICE. WHILE THE 8F UNKNOWN SHEATH DID NOT APPEAR KINKED UPON REMOVAL, A CREASE WAS OBSERVED AT THE PROXIMAL PORTION UPON CLOSER INSPECTION. THERE WAS NO VISIBLE BEND OR DAMAGE AT THE DISTAL END OF THE BALLOON SHAFT. THE FEMORAL ARTERY¿S SUITABILITY AND VESSEL DIAMETER WERE CONFIRMED VIA ANGIOGRAPHY OR VENOGRAPHY. THERE WAS NO VESSEL TORTUOSITY, CALCIFICATION, OR PERIPHERAL VASCULAR DISEASE AT THE PUNCTURE SITE. THE VESSEL DEPTH WAS NOT SHALLOW. THE MYNX VCD WAS USED DURING AN INTERVENTIONAL PROCEDURE USING A RETROGRADE APPROACH. THE DEPLOYER WAS IN TRAINING WITH THE DEVICE. THE PATIENT¿S BODY MASS INDEX (BMI) WAS NOT OVER 40 KG/M². OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. ONE NON-STERILE MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE SHOWED THAT BUTTON 1 AND BUTTON 2 WERE BOTH FULLY DEPRESSED. THE STOPCOCK WAS FOUND OPEN, WITH A CORDIS MYNX SYRINGE ATTACHED TO THE UNIT. THE SEALANT WAS DEPLOYED BUT REMAINED MOUNTED ON THE UNIT DELIVERY SHAFT. REGARDING THE SEALANT SLEEVE CONDITION, NO ABNORMALITIES WERE OBSERVED. ADDITIONALLY, A CORDIS 8F AVANTI CATHETER SHEATH INTRODUCER (CSI) WAS RETURNED INSERTED ON THE DEVICE. THE BALLOON WAS RETRACTED, AND THE CORE WIRE WAS PRESENT, WHILE THE ATRAUMATIC TIP DID NOT PRESENT ANY DAMAGE OR ABNORMAL CONDITION. NO ADDITIONAL ANOMALIES WERE OBSERVED DURING THIS ANALYSIS. A SIMULATED DEPLOYMENT TEST COULD NOT BE PERFORMED BECAUSE THE SEALANT WAS DEPLOYED BUT REMAINED MOUNTED ON THE UNIT DELIVERY SHAFT. SINCE THE UNIT WAS RECEIVED WITH AN 8F CORDIS AVANTI CSI INSERTED, THE CSI WAS FIRST REMOVED TO PERFORM AN INDEPENDENT EVALUATION OF THE INSERTION AND WITHDRAWAL FUNCTIONALITY. ADDITIONALLY, A 7F CORDIS AVANTI LABORATORY SAMPLE WAS USED FOR COMPARISON TESTING. BOTH THE RETURNED AND LABORATORY SAMPLE CSIS WERE INSERTED AND WITHDRAWN THROUGH THE UNIT WITHOUT FRICTION, RESISTANCE, OR ABNORMAL CONDITIONS. THE COMPONENTS OPERATED SMOOTHLY THROUGHOUT THE EVALUATION. A VERIFICATION WAS CONDUCTED TO CONFIRM THAT THE BALLOON WAS FULLY DEFLATED. THE BALLOON WAS RECEIVED IN A COMPLETELY RETRACTED STATE, CONFIRMING FULL DEFLATION. ADDITIONALLY, DURING VISUAL ANALYSIS, THE SEALANT SLEEVE (CARTRIDGE ASSEMBLY) WAS INSPECTED TO ENSURE IT WAS NOT FOLDED BACKWARD, AND NO ANOMALIES WERE OBSERVED. THE REPORTED EVENT OF ¿MYNX CONTROL SYSTEM-RESISTANCE/FRICTION WITH CSI¿ WAS NOT OBSERVED THROUGH ANALYSIS OF THE RETURNED DEVICE SINCE IT PASSED THE INSERTION/WITHDRAWAL TEST WITH BOTH THE PROCEDURAL SHEATH AND LAB SAMPLE SHEATH. HOWEVER, THE REPORTED EVENT OF ¿SEALANT-INACCURATE PLACEMENT-COMPLETE¿ WAS OBSERVED THROUGH ANALYSIS OF THE RETURNED DEVICE SINCE THE SEALANT WAS DEPLOYED AND REMAINED MOUNTED ON THE DELIVERY SHAFT. THE EXACT CAUSE OF THE ISSUE EXPERIENCED COULD NOT BE CONCLUSIVELY DETERMINED DURING PRODUCT EVALUATION. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND PRODUCT ANALYSIS, IT IS DIFFICULT TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE RESISTANCE EXPERIENCED WHEN THE DEVICE WAS INSERTED INTO THE PROCEDURAL SHEATH, ESPECIALLY SINCE THERE WERE NO ANOMALIES NOTED DURING THE INSERTION/WITHDRAWAL TEST. HOWEVER, AS IT WAS REPORTED THAT A CREASE WAS NOTED TO THE PROXIMAL PART OF THE SHEATH, CONCOMITANT DEVICE CONDITIONS AND/OR ACCESS SITE VESSEL CHARACTERISTICS LIKELY CONTRIBUTED TO THE ISSUE EXPERIENCED DURING THE PROCEDURE. ALSO, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED INACCURATE PLACEMENT OF THE SEALANT SINCE IT WAS RECEIVED WITH BOTH BUTTONS FULLY DEPRESSED WITH NO OTHER ISSUES NOTED. HOWEVER, PROCEDURAL/HANDLING FACTORS (SUCH AS NOT MAINTAINING FINGERTIP COMPRESSION DURING REMOVAL) ARE POSSIBLE SINCE THE USER WAS IN TRAINING AT THE TIME OF USE. ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, THE INFORMATION FOR SAFETY WITHIN THE INSTRUCTIONS FOR USE (IFU) IS PROVIDED IN THE PRODUCT¿S LABELING WITH THE INTENT TO MAKE THE USER AND PATIENT AWARE OF THE RISKS. PER THE MYNX CONTROL VENOUS IFU, STEP 1: POSITION BALLOON, ¿CAREFULLY HOLD AND INSERT THE ATRAUMATIC CATHETER TIP OF THE MYNX CONTROL VENOUS VCD 6F-12F THROUGH THE SHEATH VALVE. ALIGN THE DEVICE TO THE RELATIVE ANGLE OF THE PROCEDURAL SHEATH AND CAREFULLY ADVANCE THE CATHETER UNTIL THE SHEATH CATCH IS ADJACENT TO THE HUB OF THE SHEATH. ROTATE THE SHEATH CATCH AS NEEDED TO HOOK ONTO THE SIDEPORT OF THE PROCEDURAL SHEATH.¿ ADDITIONALLY, IFU INSTRUCTS IN STEP 3: REMOVE DEVICE, ¿FULLY RETRACT THE SYRINGE PLUNGER TO LOCK POSITION IN ORDER TO DRAW VACUUM. APPLY LIGHT FINGERTIP COMPRESSION PROXIMAL TO THE INSERTION SITE AND THEN LIGHTLY GRASP THE DEVICE AT SKIN WITH THUMB AND FOREFINGER TO STABILIZE AND REALIGN WITH THE TISSUE TRACT. OPEN THE STOPCOCK TO DEFLATE THE BALLOON. TO ENSURE COMPLETE BALLOON DEFLATION, WAIT UNTIL AIR BUBBLES AND FLUID HAVE STOPPED MOVING THROUGH THE INFLATION TUBING. PICK UP THE DEVICE HANDLE AND REALIGN WITH THE TISSUE TRACT. FULLY DEPRESS BUTTON #2 TO RETRACT THE DEFLATED BALLOON INTO THE DEVICE CATHETER. WHILE MAINTAINING FINGERTIP COMPRESSION ON THE SKIN, REMOVE THE DEVICE WITH PROCEDURAL SHEATH FROM THE PATIENT. CONTINUE TO APPLY FINGERTIP COMPRESSION FOR UP TO 1 MINUTE OR AS NEEDED. APPLY A STERILE DRESSING ONCE HEMOSTASIS IS ACHIEVED.¿ IT SHOULD BE NOTED, IF REMOVAL OF THE DEVICE IS NOT PERFORMED AS INSTRUCTED (WITH MAINTAINED FINGERTIP COMPRESSION AND REALIGNMENT WITH THE TISSUE TRACT), THE PLACEMENT OF THE SEALANT COULD BE AFFECTED. NEITHER THE PRODUCT ANALYSIS, NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGEST THAT THE REPORTED FAILURE 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, A 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) ENCOUNTERED SLIGHT RESISTANCE WHILE PASSING THROUGH AN 8F UNKNOWN SHEATH, POSSIBLY DUE TO A KINK/CREASE. THE DEVICE WAS DELIVERED AND DEPLOYED. DURING REMOVAL, AFTER BUTTON 2 WAS DEPRESSED AND THE DEVICE WAS WITHDRAWN FROM THE PATIENT, THE PEG SEALANT WAS FOUND ATTACHED TO THE END OF THE DEVICE. MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT STORED ABOVE 25°CELSIUS. THE DEVICE WAS PREPPED PROPERLY. SLIGHT RESISTANCE WAS ENCOUNTERED DURING SHEATH ENTRY, POSSIBLY INDICATING EXCESS FORCE APPLIED. BOTH BUTTON #1 AND BUTTON #2 WERE FULLY DEPRESSED, AND THE BALLOON WAS FULLY DEFLATED. THE SEALANT APPEARED TO STICK TO THE DEVICE. WHILE THE 8F UNKNOWN SHEATH DID NOT APPEAR KINKED UPON REMOVAL, A CREASE WAS OBSERVED AT THE PROXIMAL PORTION UPON CLOSER INSPECTION. THERE WAS NO VISIBLE BEND OR DAMAGE AT THE DISTAL END OF THE BALLOON SHAFT. THE FEMORAL ARTERY¿S SUITABILITY AND VESSEL DIAMETER WERE CONFIRMED VIA ANGIOGRAPHY OR VENOGRAPHY. THERE WAS NO VESSEL TORTUOSITY, CALCIFICATION, OR PERIPHERAL VASCULAR DISEASE AT THE PUNCTURE SITE. THE VESSEL DEPTH WAS NOT SHALLOW. THE MYNX VCD WAS USED DURING AN INTERVENTIONAL PROCEDURE USING A RETROGRADE APPROACH. THE DEPLOYER WAS IN TRAINING WITH THE DEVICE. THE PATIENT¿S BODY MASS INDEX (BMI) WAS NOT OVER 40 KG/M². OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10949 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP F2519205 10705032090278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8F UNKNOWN SHEATH.