BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL

    MDR report key: 18483930 · Received January 10, 2024

    Report

    Report Number
    3004939290-2024-00016
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    September 21, 2023
    Report Date
    August 1, 2024
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    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, WHILE USING A 6F/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD), THE USER ATTEMPTED TO INSERT THE SHAFT INTO A NON-CORDIS SHEATH, BUT THE SHAFT WAS BENT, SO THE DEVICE COULD NOT BE INSERTED INTO THE PATIENT'S VESSEL. THERE WAS NO TRACE OF BALLOON RUPTURE. NO PATIENT INJURIES WERE REPORTED, AND HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR TWENTY-FIVE (25) MINUTES, RESULTING IN NO EXTENDED HOSPITALIZATION. THE PATIENT RECOVERED. THE DEVICE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE AND THE PHYSICIAN WAS BEING TRAINED ON ITS USE. THE PATIENT WAS NOT MORBIDLY OBESE. THE SUITABILITY OF THE FEMORAL ARTERY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER, AS PER THE INSTRUCTIONS FOR USE (FU). THE VESSEL TYPE WAS FEMORAL ARTERIAL, AND ITS DIAMETER WAS VERIFIED TO BE GREATER THAN 5 MM. THE MYNX VCD WAS PREPARED ACCORDING TO THE IFU. THERE WAS MODERATE VESSEL TORTUOSITY; MILD VESSEL CALCIFICATION AND NO CALCIUM /PVD PRESENT IN THE VICINITY OF THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE PRIOR TO THIS PROCEDURE AND THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO MYNX VCD USE. EXCESS FORCE WAS NOT APPLIED DURING INSERTION. A NON-STERILE ¿MYNX CONTROL VCD 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 SYRINGE WAS RECEIVED SEPARATED FROM THE DEVICE, AND THE PROCEDURAL SHEATH WAS NOT RECEIVED, AND THE STOPCOCK WAS FOUND OPENED. THE SEALANT WAS FOUND PARTIALLY EXPOSED FROM THE SEALANT SLEEVES AND SWELLED FROM EXPOSURE TO BLOOD. IN ADDITION, THE BALLOON WAS RECEIVED FULLY DEFLATED, AND NO DAMAGES WERE OBSERVED TO THE SEALANT SLEEVES. PER FUNCTIONAL ANALYSIS, A SIMULATED DEPLOYMENT TEST WAS PERFORMED ON THE RETURNED DEVICE PER THE MYNX CONTROL IFU, STEP 2: DEPLOY SEALANT. BUTTON 1 WAS ABLE TO BE DEPRESSED TO DEPLOY THE SEALANT WITH NO RESISTANCE FELT. NO ISSUES WERE NOTED WITH RESPECT TO BUTTON 1 DEPLOYMENT DURING THE DEVICE FAILURE INVESTIGATION. THE RETURNED DEVICE PERFORMED AS INTENDED PER THE MYNX CONTROL IFU. PER MICROSCOPIC ANALYSIS, VISUAL INSPECTION AT HIGH MAGNIFICATION REVEALED THAT THE SEALANT WAS FOUND PARTIALLY EXPOSED FROM THE SEALANT SLEEVES AND SWELLED FROM EXPOSURE TO BLOOD. IN ADDITION, THE BALLOON WAS RECEIVED FULLY DEFLATED, AND NO DAMAGES WERE OBSERVED TO THE SEALANT SLEEVES. THE REPORTED EVENT OF ¿MYNX CONTROL SYSTEM-KINKED/BENT¿ WAS NOT CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE SINCE THERE WERE NO KINKED/BENT CONDITIONS NOTED. HOWEVER, A CONDITION WAS NOTED IN THE RETURNED DEVICE OF ¿MYNX CONTROL SYSTEM-DEPLOYMENT DIFFICULTY-PREMATURE¿ DUE TO THE PARTIALLY EXPOSED SEALANT THAT WAS SWELLED FROM BLOOD EXPOSURE. THE EXACT CAUSE OF THE OBSERVED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND PRODUCT ANALYSIS, IT IS DIFFICULT TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE ISSUE EXPERIENCED. HOWEVER, PROCEDURAL/HANDLING FACTORS (PHYSICIAN WAS BEING TRAINED ON THE DEVICE AND THE VESSEL HAD MODERATE TORTUOSITY), AND/OR THE CONDITION OF THE SHEATH (ALTHOUGH NOT RETURNED) POSSIBLY CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE CUSTOMER DURING DEVICE INSERTION, AND THE SUBSEQUENT PREMATURE EXPOSURE OF THE SEALANT. IT SHOULD BE NOTED THAT THE MYNX CONTROL DEVICE IS MANUFACTURED WITH A SLIT 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/KINKED DURING PREPPING PHASE AND/OR INSERTION INTO 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 FAILURES NOTED 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

    AFTER FURTHER REVIEW, SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER HAS BEEN CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, WHILE USING A 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD), THE USER ATTEMPTED TO INSERT THE SHAFT INTO A NON-CORDIS SHEATH, BUT THE SHAFT WAS BENT, SO THE DEVICE COULD NOT BE INSERTED INTO THE PATIENT'S VESSEL. THERE WAS NO TRACE OF BALLOON RUPTURE. NO PATIENT INJURIES WERE REPORTED, AND HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR TWENTY-FIVE (25) MINUTES, RESULTING IN NO EXTENDED HOSPITALIZATION. THE PATIENT RECOVERED. THE DEVICE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE AND THE PHYSICIAN WAS BEING TRAINED ON ITS USE. THE PATIENT WAS NOT MORBIDLY OBESE. THE SUITABILITY OF THE FEMORAL ARTERY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER, AS PER THE INSTRUCTIONS FOR USE (FU). THE VESSEL TYPE WAS FEMORAL ARTERIAL, AND ITS DIAMETER WAS VERIFIED TO BE GREATER THAN 5 MM. THE MYNX VCD WAS PREPARED ACCORDING TO THE IFU. THERE WAS MODERATE VESSEL TORTUOSITY; MILD VESSEL CALCIFICATION AND NO CALCIUM /PVD PRESENT IN THE VICINITY OF THE PUNCTURE SITE. THE TARGET FEMORAL SITE WAS NOT PREVIOUSLY CLOSED WITH ANY CLOSURE DEVICE PRIOR TO THIS PROCEDURE AND THERE WAS NO EVIDENCE OF PRE-EXISTING HEMATOMA, ARTERIOVENOUS FISTULA, OR PSEUDOANEURYSM AT THE ACCESS SITE PRIOR TO MYNX VCD USE. EXCESS FORCE WAS NOT APPLIED DURING INSERTION. THE DEVICE WAS RETURNED FOR EVALUATION. ACCORDING TO THE PRODUCT EVALUATION, THE SEALANT WAS FOUND PARTIALLY EXPOSED FROM THE SEALANT SLEEVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552446 MYNX CONTROL DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA F2311703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 7F TERUMO RADIOFOCUS INTRODUCER KIT.