BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL

    MDR report key: 20145182 · Received September 5, 2024

    Report

    Report Number
    3004939290-2024-00486
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 5, 2024
    Manufacturer
    CARDINAL HEALTH SANTA CLARA
    Product Code
    MGB
    UDI-DI
    20862028000455
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, THE ATRAUMATIC TIP OF A 6F/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) DID NOT ENTER THE 6F NON-CORDIS SHEATH. THEREFORE, THE PRODUCT WAS NOT AVAILABLE, AND MANUAL COMPRESSION WAS PERFORMED FOR TWENTY MINUTES AND RECOVERED. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE MYNX CONTROL VESSEL CLOSURE UNIT WAS PREPARED AND USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). EXCESS FORCE WAS NOT APPLIED DURING INSERTION. THE 6F NON-CORDIS SHEATH WAS NOT KINKED/BENT UPON REMOVAL. THERE WAS NO VISIBLE BEND/DAMAGE IN THE DISTAL END OF THE BALLOON SHAFT AFTER REMOVAL. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE UNKNOWN VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN 5 MM. THE PUNCTURE SITE DID NOT HAVE VISIBLE CALCIUM/PLAQUE. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO STENT NEAR THE PUNCTURE SITE. THE VESSEL DID NOT HAVE STENOSIS >50% AT THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE LESS THAN THIRTY DAYS PRIOR TO THIS PROCEDURE. THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO USING MYNX CONTROL. THE MYNX VCD WAS USED IN PERCUTANEOUS CORONARY INTERVENTION (PCI) AND USED A RETROGRADE APPROACH. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF MYNX AND HAS USED THE DEVICE SEVERAL TIMES PRIOR TO THIS PROCEDURE. THE PATIENT¿S BODY MASS INDEX (BMI) WAS NOT GREATER THAN 40 KG/M². OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. A NON-STERILE MYNX CONTROL VASCULAR CLOSURE DEVICE 6F/7F INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RECEIVED DEVICE SHOWED THAT BOTH BUTTON 1 AND BUTTON 2 WERE NOT DEPRESSED. THE SEALANT REMAINED IN ITS MANUFACTURED POSITION; NEVERTHELESS, IT WAS EXPOSED DUE TO A FRAYED/SPLIT CONDITION OBSERVED TO THE SEALANT SLEEVES. THE SYRINGE USED IN THE PROCEDURE WAS RETURNED ATTACHED TO THE UNIT, BUT THE PROCEDURAL SHEATH WAS NOT RETURNED WITH THE DEVICE. PER FUNCTIONAL ANALYSIS, A CORRESPONDING 6F CATHETER SHEATH INTRODUCER (CSI) WAS INTRODUCED AND WITHDRAWN PER THE FUNCTIONAL ANALYSIS EXECUTED. THIS EVALUATION WAS EXECUTED WITHOUT PERCEIVING ANY FRICTION OR RESISTANCE THAT COULD IMPEDE THE PHYSICIAN FROM FOLLOWING THE PROCEDURE. A MICROSCOPIC ANALYSIS WAS PERFORMED TO EVALUATE THE CONDITION OF THE SEALANT SLEEVES. DURING THIS ANALYSIS, IT WAS OBSERVED THAT THE SEALANT SLEEVES WERE SPLIT, RESULTING IN THE PREMATURE EXPOSURE OF THE SEALANT. THE REPORTED EVENT OF ¿MYNX CONTROL SYSTEM-IMPEDED¿ WAS NOT CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE SINCE THE DEVICE PASSED FUNCTIONAL ANALYSIS WITH THE INSERTION/WITHDRAW TEST ON THE LAB SAMPLE CSI. HOWEVER, AN ADDITIONAL CONDITION OF ¿MYNX CONTROL SYSTEM-DEPLOYMENT DIFFICULTY-PREMATURE¿ WAS NOTED DUE TO THE EXPOSED SEALANT FROM FRAYED/SPLIT/TORN SEALANT SLEEVES. THE EXACT CAUSE OF THE ISSUES EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND PRODUCT ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE IMPEDANCE EXPERIENCED BY THE CUSTOMER, OR THE EXPOSED SEALANT / DAMAGED SEALANT SLEEVES NOTED DURING VISUAL ANALYSIS. HOWEVER, PROCEDURAL/HANDLING FACTORS (ALTHOUGH THE CUSTOMER REPORTED THAT EXCESS FORCE WAS NOT APPLIED DURING INSERTION) AND/OR THE CONDITION OF THE PROCEDURAL SHEATH (WHICH WAS NOT RETURNED FOR ANALYSIS) ARE LIKELY SINCE THE DEVICE COULD BE INSERTED/WITHDRAWN INTO THE LAB SAMPLE CSI WITH NO RESISTANCE FELT DURING FUNCTIONAL ANALYSIS. IT SHOULD BE NOTED THAT THE MYNX CONTROL DEVICE IS MANUFACTURED WITH SLITS AT THE END OF THE CATHETER CARTRIDGE TUBING. THE OUTER SLEEVE 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 VCD WITHIN THE IFU DISPLAYING THE SEALANT SLEEVE WITH SLIT. IF THE OUTER SLEEVE IS DAMAGED/SHREDDED DURING PREPPING PHASE AND/OR INSERTION INTO THE SHEATH, IT COULD CAUSE THE SEALANT TO BE EXPOSED/SWOLLEN PREMATURELY AND/OR OBSTRUCT THE DEVICE PATH AND PREVENT THE DEVICE FROM BEING INSERTED INTO THE PROCEDURAL SHEATH. AS WARNED IN THE IFU, WHICH IS NOT INTENDED AS A MITIGATION, ¿DO NOT USE IF COMPONENTS OR PACKAGING APPEAR TO BE DAMAGED OR DEFECTIVE OR IF ANY PORTION OF THE PACKAGING HAS BEEN PREVIOUSLY OPENED.¿ ADDITIONALLY, THE IFU STATES ¿STEP 1: POSITION BALLOON, INSERT THE MYNX CONTROL VCD INTO THE PROCEDURAL SHEATH THROUGH THE SHEATH VALVE. ADVANCE THE CATHETER UNTIL THE SHEATH CATCH NEARS THE HUB OF THE SHEATH. ROTATE THE SHEATH CATCH AS NEEDED TO HOOK ONTO THE SIDE PORT OF THE PROCEDURAL SHEATH.¿ NEITHER THE PRODUCT ANALYSIS, NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGEST THAT THE REPORTED FAILURE AND NOTED CONDITION 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, THE ATRAUMATIC TIP OF A 6/7FMYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) DID NOT ENTER THE 6F NON-CORDIS SHEATH. THEREFORE, THE PRODUCT WAS NOT AVAILABLE AND MANUAL COMPRESSION WAS PERFORMED FOR TWENTY MINUTES AND RECOVERED. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE MYNX CONTROL VESSEL CLOSURE UNIT WAS PREPARED AND USED IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) INSTRUCTIONS. EXCESS FORCE WAS NOT APPLIED DURING INSERTION. THE 6F NON-CORDIS SHEATH WAS NOT KINKED/BENT UPON REMOVAL. THERE WAS NO VISIBLE BEND/DAMAGE IN DISTAL END OF THE BALLOON SHAFT AFTER REMOVAL. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30~45 DEGREES) OF THE UNKNOWN VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN 5MM IN DIAMETER. THE PUNCTURE SITE DID NOT HAVE VISIBLE CALCIUM/PLAQUE. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO STENT NEAR THE PUNCTURE SITE. THE VESSEL DID NOT HAVE STENOSIS >50% AT THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE LESS THAN THIRTY DAYS PRIOR TO THIS PROCEDURE. THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO USE MYNX CONTROL. THE MYNX VCD USED IN PERCUTANEOUS CORONARY INTERVENTION (PCI) AND USED A RETROGRADE APPROACH. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF MYNX AND HAS USED THE DEVICE SEVERAL TIMES PRIOR TO THIS PROCEDURE. THE PATIENT¿S BMI WAS NOT GREATER THAN 40 KG/M2. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PRODUCT EVALUATION, IT WAS OBSERVED THAT THE SEALANT SLEEVES WERE SPLIT RESULTING IN THE PREMATURE EXPOSURE OF THE SEALANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139770 MYNX CONTROL DEVICE, HEMOSTASIS, VASCULAR MGB CARDINAL HEALTH SANTA CLARA F2400502 20862028000455

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 6F TERUMO SHEATH