BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    MDR report key: 15297864 · Received August 25, 2022

    Report

    Report Number
    3004939290-2022-02678
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    July 15, 2022
    Report Date
    September 14, 2022
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000410
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    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 # 3004939290-2022-02679. AS REPORTED, TWO 6/7F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) WERE USED ON A PATIENT. ON ONE, THE BALLOON POPPED AND ON THE OTHER DEVICE, IT HAD A PORTION OF THE SEALANT STILL ATTACHED TO THE CATHETER WHEN IT WAS TAKEN OUT. THERE WAS NO REPORTED PATIENT INJURY. THE USER WAS TRAINED TO THE DEVICES. 192635-1 THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE MYNXGRIP VASCULAR CLOSURE DEVICE 6/7F INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, THE SHUTTLE CARTRIDGE WAS ENGAGED TO THE BLACK HANDLE, THE SYRINGE WAS CONNECTED TO THE DEVICE WITH THE STOPCOCK OPEN. THE SEALANT WAS NOT RETURNED WITH THE DEVICE AND THE ADVANCER TUBE WAS RETURNED SEPARATELY. THE DEVICE WAS RETURNED IN A COMPLETE REMOVAL STATE. THE PROCEDURAL SHEATH WAS RETURNED WITH THE DEVICE. PER FUNCTIONAL ANALYSIS, LEAK TESTING WAS PERFORMED ON THE BALLOON OF THE RETURNED DEVICE AND NO LEAK IN THE BALLOON WAS FOUND. PRESSURE WAS MAINTAINED WITH PROPER FUNCTIONING OF THE INFLATION INDICATOR. THE INFLATED BALLOON DIAMETER WAS VERIFIED AND NOTED TO BE WITHIN SPECIFICATION. PER DIMENSIONAL ANALYSIS, THE INFLATED BALLOON DIAMETER WAS VERIFIED AND NOTED TO BE WITHIN SPECIFICATION. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2213804 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. 192635-2 THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿BALLOON LOSS OF PRESSURE¿ WAS NOT CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICE. THE REPORTED ¿SEALANT STUCK TO DEVICE COMPONENTS¿ COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL AND 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 EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, TWO 6/7F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) WERE USED ON A PATIENT. ON ONE, THE BALLOON POPPED AND ON THE OTHER DEVICE, IT HAD A PORTION OF THE SEALANT STILL ATTACHED TO THE CATHETER WHEN IT WAS TAKEN OUT. THERE WAS NO REPORTED PATIENT INJURY. THE USER IS TRAINED TO THE DEVICES. THE DEVICES WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367598 MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6721 F2213804 10862028000410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown