BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL VCD 6F 7F

    MDR report key: 16257455 · Received January 27, 2023

    Report

    Report Number
    3004939290-2023-02864
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    January 4, 2023
    Report Date
    March 16, 2023
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HISTORY REVIEW IS EXPECTED BUT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: G3, G6, H1, H2, H3, H6, AND H10. THIS REPORT IS RELATED TO REPORT # 3004939290-2023-02865. COMPLAINT CONCLUSION: AS REPORTED, THE BALLOONS OF TWO 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICES (VCDS) LOST INFLATION ONCE IT WAS INTRODUCED INTO THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE THIRD UNKNOWN MYNX DEVICE WORKED WELL. THE MYNX VCD WAS USED IN A DIAGNOSTIC PROCEDURE. THE PROCEDURE USED AN ANTEGRADE APPROACH. THE DEPLOYER IS MYNX CERTIFIED. A 6F NON-CORDIS SHEATH WAS USED. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS NO PRIOR PTA, STENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY OR VEIN. THERE WAS MODERATE CALCIFICATION IN THE VICINITY OF THE PUNCTURE SITE. 205291-1 THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE MYNX CONTROL VASCULAR CLOSURE DEVICE 6F7F INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, BOTH BUTTON 1 AND BUTTON 2 WERE NOT DEPRESSED WITH THE STOPCOCK OPEN, THE SYRINGE WAS RECEIVED CONNECTED TO THE DEVICE. THE SEALANT REMAINED IN THE MANUFACTURING POSITION. BLOOD RESIDUES WERE OBSERVED. THE PROCEDURAL SHEATH WAS NOT RETURNED. PER FUNCTIONAL ANALYSIS, INFLATION/DEFLATION TESTING WAS PERFORMED ON THE BALLOON OF THE RETURNED DEVICE, AND THE RESULTS REVEALED A LEAK IN THE BALLOON. PER MICROSCOPIC ANALYSIS, A MICROTEAR WAS OBSERVED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2229916 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. 205291-2 THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE MYNX CONTROL VASCULAR CLOSURE DEVICE 6F7F INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, BUTTON 1 AND BUTTON 2 WERE NOT DEPRESSED WITH THE STOPCOCK OPEN, THE SYRINGE WAS RECEIVED CONNECTED TO THE DEVICE. THE SEALANT REMAINED IN THE MANUFACTURING POSITION. BLOOD RESIDUES WERE OBSERVED. THE PROCEDURAL SHEATH WAS NOT RETURNED. PER FUNCTIONAL ANALYSIS, INFLATION/DEFLATION TESTING WAS PERFORMED ON THE BALLOON OF THE RETURNED DEVICE, AND THE RESULTS REVEALED A LEAK IN THE BALLOON. PER MICROSCOPIC ANALYSIS, A LONGITUDINAL TEAR WAS OBSERVED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2229916 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON LOSS OF PRESSURE¿ WAS CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICES. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL OR HANDLING FACTORS, MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, USERS ARE INSTRUCTED NOT TO USE THE DEVICE IF THE BALLOON DOES NOT MAINTAIN PRESSURE. NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENTS COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: G3, G6, H1, H2, H6, AND H10 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. THIS REPORT IS RELATED TO REPORT # 3004939290-2023-02865.

    Description of Event or Problem · 0

    AS REPORTED, THE BALLOONS OF TWO 6/7F MYNX CONTROL VASCULAR CLOSURE DEVICES (VCDS) LOST INFLATION ONCE IT WAS INTRODUCED INTO THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE THIRD UNKNOWN MYNX DEVICE WORKED WELL. THE MYNX VCD WAS USED IN A DIAGNOSTIC PROCEDURE. THE PROCEDURE USED AN ANTEGRADE APPROACH. THE DEPLOYER IS MYNX CERTIFIED. A 6F NON-CORDIS SHEATH WAS USED. THE FEMORAL ARTERY¿S SUITABILITY WAS VERIFIED ON ANGIOGRAPHY, INCLUDING THE INSERTION ANGLE (30-45 DEGREES) OF THE VASCULAR SHEATH INTRODUCER. THE VESSEL DIAMETER WAS VERIFIED TO BE GREATER THAN OR EQUAL TO 5 MM IN DIAMETER. THERE WAS NO PRIOR PTA, STENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY OR VEIN. THERE WAS MODERATE CALCIFICATION IN THE VICINITY OF THE PUNCTURE SITE. THE DEVICES WILL BE RETURNED FOR EVALUATION, HOWEVER THE SHEATH WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485682 MYNX CONTROL VCD 6F 7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6760 F2229916

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male MYNX CONTROL DEVICE, 6F BSX SHEATH.