BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CONTROL VENOUS

    MDR report key: 19973816 · Received August 13, 2024

    Report

    Report Number
    3004939290-2024-00427
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 2, 2024
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    UDI-DI
    10705032090278
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: G3, G6, H2, H3, H6, AND H10. THIS DEVICE HAS BEEN ANALYZED BUT THE FINAL, APPROVED DRAFT OF THE ENGINEERING REPORT AND ITS CONCLUSION IS NOT YET AVAILABLE DUE TO NEED FOR ADDITIONAL TESTING. 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, AFTER THE 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS PREPPED AND USED IN A NORMAL FASHION, THE SEALANT WAS FOUND STUCK ON THE DEVICE NEAREST THE TAMP TUBE END DURING REMOVAL AFTER BALLOON DEFLATION AND PRESSING BUTTON NUMBER 2. THIS RESULTED IN HEMOSTASIS NOT BEING ACHIEVED. MANUAL PRESSURE WAS APPLIED, AND A FIGURE-OF-EIGHT STITCH WAS USED. THE FIGURE-OF-EIGHT STITCH WAS PERFORMED AS A SAFETY FEATURE. THE PHYSICIAN FELT A FIGURE-OF-EIGHT STITCH OVER THE TOP OF THE ¿MYNXED¿ VEIN PROVIDED ADDITIONAL SECURITY AND MAINTAINED THE PATIENT¿S ¿TTA¿ AND ¿TTDE¿. THERE WERE NO REPORTS OF PATIENT INJURY AS NO PATIENT COMPLICATIONS WERE COMMUNICATED. DURING THE PROCEDURE, A FIGURE-OF-EIGHT STITCH WAS UTILIZED FOR HEMOSTASIS, AND BUTTON #2 WAS DEPRESSED BEFORE DEVICE REMOVAL. THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT EXCEEDING A STORAGE TEMPERATURE OF 25 °C. THE MYNX VCD, USED IN AN INTERVENTIONAL WATCHMAN DEVICE PROCEDURE, EMPLOYED A RETROGRADE APPROACH BY A TRAINED DEPLOYER. A 12F UNKNOWN SHEATH INTRODUCER WAS USED ON THE VENOUS VESSEL, WHICH WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER, WITH NO VESSEL TORTUOSITY. THE PROCEDURE INVOLVED THE FEMORAL VEIN, WHERE THE SEALANT WAS DEPLOYED COMPLETELY ABOVE THE ACCESS SITE, PARTIALLY OUT OF THE SKIN, AND IT ADHERED TO THE DEVICE. THE PATIENT HAD NO ISSUES AND WAS DISCHARGED AT THE NORMAL TIME WITHOUT ANY INJURY DURING THE PROCEDURE. A NON-STERILE ¿MYNX CONTROL VENOUS VCD¿ WAS RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, THE UNIT WAS THOROUGHLY INSPECTED, OBSERVING THAT BUTTON #1 WAS FULLY DEPRESSED. HOWEVER, BUTTON #2 WAS NOT DEPRESSED, AND THE BALLOON WAS NOT WITHDRAWN INTO THE TAMP TUBE. THE SYRINGE WAS RETURNED FOR ANALYSIS, ATTACHED TO THE LUER HUB. THE CATHETER WAS PROPERLY INSERTED INTO AN UNKNOWN NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) AND LOCKED ONTO THE SHEATH CATCH. THE SEALANT WAS NOT RETURNED WITH THE DEVICE. THE DEVICE WAS INSPECTED FOR DAMAGES/ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE, AND NO DAMAGES/ANOMALIES WERE OBSERVED. PER FUNCTIONAL ANALYSIS, A SIMULATED DEPLOYMENT TEST WAS PERFORMED ON THE RETURNED DEVICE PER THE MYNX CONTROL IFU. SINCE BUTTON #1 IS ALREADY DEPRESSED, ONLY BUTTON #2 WAS DEPRESSED TO WITHDRAW THE BALLOON WITH NO RESISTANCE FELT. NO ISSUES WERE NOTED WITH RESPECT TO BUTTON #2 DURING THE DEVICE FAILURE INVESTIGATION. THE RETURNED DEVICE PERFORMED AS INTENDED PER THE MYNX CONTROL IFU. THE REPORTED EVENT OF SEALANT-INACCURATE PLACEMENT-COMPLETE¿ WAS NOT CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE DUE TO THE NATURE OF THE COMPLAINT AND BASED ON THE RETURNED CONDITION. THE EXACT CAUSE OF THE ISSUE EXPERIENCED COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND PRODUCT ANALYSIS, USER ERROR LIKELY RESULTED IN THE INACCURATE PLACEMENT OF THE SEALANT REPORTED AS THE DEVICE WAS RECEIVED WITHOUT BUTTON 2 DEPRESSED (EVEN THOUGH IT WAS REPORTED THAT BUTTON#2 WAS DEPRESSED BEFORE DEVICE REMOVAL). PER THE MYNX CONTROL VENOUS IFU, STEP 3: REMOVE DEVICE, WHICH IS NOT INTENDED AS A MITIGATION, ¿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 THE DEVICE IS REMOVED BEFORE COMPLETING BALLOON DEFLATION OR COMPLETE DEPRESSION OF BUTTON 2, THE SEALANT COULD BE DISLODGED FROM THE VESSEL WALL. ALSO, THE REPORTED ADDITIONAL INTERVENTION OF ¿SUTURE INSERTION¿ AFTER THE SEALANT WAS REMOVED WITH THE DEVICE WAS REPORTED FOR THIS COMPLAINT. WITHOUT IMAGES OF THE ACCESS SITE CONDITION, IT¿S NOT POSSIBLE TO DETERMINE IF THERE WAS A PRODUCT CONTRIBUTING CAUSE OR CONFIRM ANY ADDITIONAL CONDITION. HOWEVER, AS IT WAS REPORTED THAT THE SUTURING WAS PROVIDED AS ADDITIONAL SECURITY WITH NO FURTHER COMPLICATIONS REPORTED, IT WAS LIKELY PERFORMED DUE TO THE PHYSICIAN¿S PREFERENCE. 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.

    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, AFTER THE 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS PREPPED AND USED IN A NORMAL FASHION, THE SEALANT WAS FOUND STUCK ON THE DEVICE NEAREST THE TAMP TUBE END DURING REMOVAL AFTER BALLOON DEFLATION AND PRESSING BUTTON NUMBER 2. THIS RESULTED IN HEMOSTASIS NOT BEING ACHIEVED. MANUAL PRESSURE WAS APPLIED, AND A FIGURE-OF-EIGHT STITCH WAS USED. THE FIGURE OF EIGHT STITCH WAS PERFORMED AS A SAFETY FEATURE. THE PHYSICIAN FELT A FIGURE OF 8 STITCH OVER THE TOP OF THE MYNXED VEIN PROVIDED ADDITIONAL SECURITY AND MAINTAINED THE PATIENTS "TTA" AND "TTDE". THERE WERE NO REPORTS OF PATIENT INJURY AS NO PATIENT COMPLICATIONS WERE COMMUNICATED. DURING THE PROCEDURE, A FIGURE OF EIGHT STITCH WAS UTILIZED FOR HEMOSTASIS, AND BUTTON #2 WAS DEPRESSED BEFORE DEVICE REMOVAL. THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT EXCEEDING A STORAGE TEMPERATURE OF 25 °C. THE MYNX VCD, USED IN AN INTERVENTIONAL WATCHMAN DEVICE PROCEDURE, EMPLOYED A RETROGRADE APPROACH BY A TRAINED DEPLOYER. A 12F UNKNOWN SHEATH INTRODUCER WAS USED ON THE VENOUS VESSEL, WHICH WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER, WITH NO VESSEL TORTUOSITY. THE PROCEDURE INVOLVED THE FEMORAL VEIN, WHERE THE SEALANT WAS DEPLOYED COMPLETELY ABOVE THE ACCESS SITE, PARTIALLY OUT OF THE SKIN, AND IT ADHERED TO THE DEVICE. THE PATIENT HAD NO ISSUES AND WAS DISCHARGED AT THE NORMAL TIME WITHOUT ANY INJURY DURING THE PROCEDURE. THE DEVICE WAS SAVED AND WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, AFTER THE 6/7 F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS PREPPED AND USED IN A NORMAL FASHION, THE SEALANT WAS FOUND STUCK ON THE DEVICE NEAREST THE TAMP TUBE END DURING REMOVAL AFTER BALLOON DEFLATION AND PRESSING BUTTON NUMBER 2. THIS RESULTED IN HEMOSTASIS NOT BEING ACHIEVED. MANUAL PRESSURE WAS APPLIED, AND A FIGURE-OF-EIGHT STITCH WAS USED. THERE WERE NO REPORTS OF PATIENT INJURY AS NO PATIENT COMPLICATIONS WERE COMMUNICATED. DURING THE PROCEDURE, A FIGURE OF EIGHT STITCH WAS UTILIZED FOR HEMOSTASIS, AND BUTTON #2 WAS DEPRESSED BEFORE DEVICE REMOVAL. THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITHOUT EXCEEDING A STORAGE TEMPERATURE OF 25 °C. THE MYNX VCD, USED IN AN INTERVENTIONAL WATCHMAN DEVICE PROCEDURE, EMPLOYED A RETROGRADE APPROACH BY A TRAINED DEPLOYER. A 12F UNKNOWN SHEATH INTRODUCER WAS USED ON THE VENOUS VESSEL, WHICH WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER, WITH NO VESSEL TORTUOSITY. THE PROCEDURE INVOLVED THE FEMORAL VEIN, WHERE THE SEALANT WAS DEPLOYED COMPLETELY ABOVE THE ACCESS SITE, PARTIALLY OUT OF THE SKIN, AND IT ADHERED TO THE DEVICE. THE PATIENT HAD NO ISSUES AND WAS DISCHARGED AT THE NORMAL TIME. THE DEVICE WAS SAVED AND WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093864 MYNX CONTROL VENOUS DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP. NA F2413001 10705032090278

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention N/A.