BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 21452991 · Received February 24, 2025

    Report

    Report Number
    3004939290-2025-00161
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    January 29, 2025
    Report Date
    March 27, 2025
    Manufacturer
    CARDINAL HEALTH SANTA HEALTH
    Product Code
    MGB
    UDI-DI
    10705032090278
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE BALLOON ON A 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) PULLED THROUGH DUE TO BEING UNDERINFLATED. THE PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED USING MANUAL PRESSURE FOR UNDER 30 MINUTES. THERE WERE NO REPORTS OF PATIENT INJURY. THE MYNX VCD WAS USED IN AN INTERVENTIONAL PROCEDURE BY A CERTIFIED USER. AN 11F NON-CORDIS SHEATH INTRODUCER WAS USED. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM. THE MYNX VCD WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE BALLOON DID NOT LOSE PRESSURE. THE DEVICE WAS PURGED OF AIR DURING PREP. THERE WAS NO SCAR TISSUE PRESENT AT THE PUNCTURE SITE, NO EXCESSIVE TENSION WAS APPLIED TO THE DEVICE, AND THERE WERE MULTIPLE SHEATH EXCHANGES PRIOR TO THE USE OF THE MYNX DEVICE. A NON-STERILE ¿MYNX CONTROL VENOUS VCD¿ WAS RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, THE UNIT WAS THOROUGHLY INSPECTED, AND IT WAS OBSERVED THAT BOTH BUTTON 1 AND BUTTON 2 WERE NOT DEPRESSED. THE SYRINGE WAS CONNECTED TO THE STOPCOCK, AND THE CATHETER WAS PROPERLY INSERTED INTO AN UNKNOWN NON-CORDIS 11 FRENCH SHEATH, LOCKED ONTO THE SHEATH CATCH. THE SEALANT WAS IN ITS MANUFACTURED POSITION, EXPOSED DUE TO A SEVERE KINK OF THE CARTRIDGE ASSEMBLY. THE STOPCOCK WAS SET TO THE OPEN POSITION, AND THE ATRAUMATIC TIP DID NOT PRESENT ANY DAMAGES OR ANOMALIES. NO OTHER OUTSTANDING DETAILS WERE NOTICED. THE SLIT LENGTH ON THE OUTER SLEEVE WAS NOT VERIFIED DUE TO THE SEVERE OUTWARD KINK TO THE SEALANT SLEEVE ASSEMBLY. HOWEVER, THE CATHETER WORKING LENGTH WAS MEASURED, AND THE DIMENSIONAL ANALYSIS RESULT WAS FOUND WITHIN SPECIFICATION. THE BALLOON INFLATION OUTER DIAMETER (OD) WAS INSPECTED, AND DIMENSIONAL ANALYSIS RESULTS WERE ALSO FOUND WITHIN SPECIFICATION. PER FUNCTIONAL ANALYSIS, AN INFLATION/DEFLATION TEST WAS PERFORMED BY INJECTING WATER INTO THE RETURNED DEVICE. THE BALLOON INFLATED AND DEFLATED AS EXPECTED, AND THE INFLATION INDICATOR POPPED UP. THE SIMULATED INSERTION/WITHDRAWAL TESTS INTO THE RETURNED NON-CORDIS SHEATH AND INTO A LAB SAMPLE WERE PERFORMED. THE NON-CORDIS CSI WAS WITHDRAWN FROM THE RETURNED UNIT AND THEN ATTEMPTED TO BE RE-INSERTED. HOWEVER, DUE TO THE SEVERE KINK AT THE CARTRIDGE ASSEMBLY, IT WAS NOT POSSIBLE TO RE-INSERT THE DEVICE INTO THE CANNULA OF THE SHEATH. NEITHER WAS THE RETURNED UNIT ABLE TO BE INSERTED INTO THE LAB SAMPLE DUE TO THE KINKED CONDITION OF THE CARTRIDGE ASSEMBLY. A SIMULATED DEPLOYMENT TEST WAS PERFORMED ON THE RETURNED DEVICE PER THE MYNX CONTROL IFU. THE TENSION INDICATOR WAS MANUALLY ALIGNED, THEN BUTTONS 1 AND 2 WERE ABLE TO BE DEPRESSED TO DEPLOY THE SEALANT AND WITHDRAW THE BALLOON WITHOUT ANY RESISTANCE. NO ISSUES WERE NOTED WITH RESPECT TO THE DEPLOYMENT OF BUTTONS 1 AND 2 DURING THE DEVICE FAILURE INVESTIGATION. THE RETURNED DEVICE PERFORMED AS INTENDED PER THE MYNX CONTROL IFU. PER MICROSCOPIC ANALYSIS, THE CARTRIDGE ASSEMBLY WAS INSPECTED WITH A VISION SYSTEM TO OBTAIN A MAGNIFIED IMAGE, CONFIRMING THE KINKED CONDITION AND OBSERVING THAT THE SEALANT WAS EXPOSED. THE REPORTED EVENT OF ¿BALLOON-PULL THROUGH¿ WAS NOT OBSERVED THROUGH ANALYSIS OF THE RETURNED DEVICE SINCE THE DEVICE PASSED DIMENSIONAL AND FUNCTIONAL ANALYSIS. HOWEVER, A CONDITION WAS NOTED WITH THE RETURNED DEVICE OF ¿MYNX CONTROL SYSTEM-DEPLOYMENT DIFFICULTY-PREMATURE¿ DUE TO THE EXPOSED SEALANT FROM THE KINKED SLEEVES. THE EXACT CAUSE OF THE ISSUE EXPERIENCED AND THE OBSERVED CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND PRODUCT ANALYSIS, PROCEDURAL/HANDLING FACTORS (IT REPORTEDLY PULLED THROUGH THE VENOTOMY DUE TO BEING UNDERINFLATED) LIKELY CONTRIBUTING TO THE REPORTED PULL THROUGH EXPERIENCED, ESPECIALLY SINCE THERE WERE NO ANOMALIES NOTED TO THE BALLOON DURING ANALYSIS. ADDITIONALLY, PROCEDURAL/HANDLING FACTORS ALSO MAY HAVE CONTRIBUTED TO THE DAMAGED CONDITION OF THE SEALANT SLEEVES, AND THE SUBSEQUENT PREMATURE EXPOSURE OF THE SEALANT. IT SHOULD BE NOTED THAT THE MYNX CONTROL VENOUS DEVICE IS MANUFACTURED WITH A SLIT AT THE END OF THE CATHETER CARTRIDGE TUBING. THE OUTER SLEEVE ASSEMBLY IS ASSEMBLED WITH 2 SIDE SLIT OVERLAPPING OUTER SLEEVES. THE SEALANT IS PLACED RIGHT UNDER THE OUTER SLEEVE ASSEMBLY AND IS PROTECTED FROM EXPOSING PREMATURELY. THE SLITS ON THE OUTER SLEEVE ASSEMBLY ARE DESIGNED TO DECREASE UNSHEATHING FORCE AND INCREASE DEPLOYMENT RELIABILITY. REFER TO THE DIAGRAM OF THE MYNX CONTROL VENOUS VCD WITHIN THE IFU DISPLAYING THE SEALANT SLEEVE SLIT. IF THE OUTER SLEEVE IS DAMAGED/KINKED DURING PREPPING PHASE AND/OR INSERTION INTO THE SHEATH, IT COULD CAUSE THE SEALANT TO BE EXPOSED/SWOLLEN PREMATURELY. HOWEVER, AS THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER, IT IS UNKNOWN IF THIS RECEIVED CONDITION OCCURRED DUE TO MANIPULATIONS AFTER THE PROCEDURE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, ONCE THE DEVICE IS INSERTED INTO THE SHEATH, THE IFU INSTRUCTS TO ¿INFLATE THE BALLOON UNTIL THE INFLATION INDICATOR ON THE BACK OF THE DEVICE HANDLE EXTENDS SO THAT THE ENTIRE BLACK MARKER IS FULLY VISIBLE WITH WHITE BORDER ON EITHER SIDE AND CLOSE STOPCOCK. ALIGN THE DEVICE WITH THE TISSUE TRACT. PULL GENTLY TO RETRACT THE DEVICE AND PROCEDURAL SHEATH UNTIL THE BLACK LINE IN THE TENSION INDICATOR WINDOW ALIGNS WITH THE MARKS ON BOTH SIDES OF THE WHITE HANDLE. THIS INDICATES THAT THE BALLOON IS ABUTTING THE VENOTOMY AND THAT THE DEVICE IS POSITIONED TO APPROPRIATELY DELIVER THE SEALANT EXTRAVASCULAR TO THE VENOTOMY.¿ THE IFU ALSO WARNS, ¿DO NOT USE IF THE MYNX CONTROL VENOUS VCD 6F-12F COMPONENTS OR PACKAGING APPEAR TO BE DAMAGED OR DEFECTIVE OR IF ANY PORTION OF THE PACKAGING HAS BEEN PREVIOUSLY OPENED.¿ NEITHER THE PRODUCT ANALYSIS, NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGEST THAT THE ISSUES EXPERIENCED COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    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.

    Description of Event or Problem · 0

    AS REPORTED, THE BALLOON ON A 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) PULLED THROUGH DUE TO BEING UNDER INFLATED. THE PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED USING MANUAL PRESSURE FOR UNDER 30 MINUTES. THERE WERE NO REPORTS OF PATIENT INJURY. THE MYNX VCD WAS USED IN AN INTERVENTIONAL PROCEDURE BY A CERTIFIED USER. AN 11F NON-CORDIS SHEATH INTRODUCER WAS USED. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM. THE MYNX VCD WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE BALLOON DID NOT LOSE PRESSURE. THE DEVICE WAS PURGED OF AIR DURING PREP. THERE WAS NO SCAR TISSUE PRESENT AT THE PUNCTURE SITE, NO EXCESSIVE TENSION WAS APPLIED TO THE DEVICE, AND THERE WERE MULTIPLE SHEATH EXCHANGES PRIOR TO THE USE OF THE MYNX DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557291 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB CARDINAL HEALTH SANTA HEALTH NA F2429902 10705032090278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.