BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 15124665 · Received July 28, 2022

    Report

    Report Number
    3004939290-2022-02647
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 31, 2022
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000403
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD (DHR) REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE TAMP TUBE OF FIVE 5F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) GOT STUCK IN THE HOUSING. NO INJURY WAS REPORTED TO THE PATIENT. 190156-1: THE PRODUCT WAS RETURNED FOR ANALYSIS. A TOTAL OF 2 NON-STERILE MYNXGRIP VASCULAR CLOSURE DEVICES 5F INVOLVED IN THE REPORTED COMPLAINT WERE RETURNED FOR INVESTIGATION. PER VISUAL ANALYSIS, THE DEVICES WERE RECEIVED IN THEIR ORIGINAL PACKAGING CASE WITHOUT THE POUCH. THE DEVICES WERE UNUSED, AND THE SEALANT WAS OBSERVED TO BE EXPOSED TO MOISTURE AND ADHERED TO THE CATHETER. PER FUNCTIONAL ANALYSIS, THE SEALANT WAS RELEASED ON BOTH DEVICES, AND THE SHUTTLE DOWN PROCEDURE WAS SIMULATED. THE SHUTTLE CARTRIDGE WAS ABLE TO BE ADVANCED AND RETRACTED TO THE BLACK HANDLE WITH NO RESISTANCE FELT. THE ADVANCER TUBE WAS PROPERLY ENGAGED TO PROXIMAL TAMP LOCK AS INTENDED PER THE MYNXGRIP INSTRUCTIONS FOR USE (IFU). PER MICROSCOPIC ANALYSIS, THE TAMP LOCKS WERE INSPECTED AT HIGH MAGNIFICATION FOR DAMAGES THAT MAY HAVE PREVENTED THE ADVANCER TUBE FROM ENGAGING TO THE PROXIMAL TAMP LOCK, AND NO DAMAGES OR ANOMALIES WERE OBSERVED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2216101 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿SEALANT FAILURE TO DEPLOY - ADVANCER TUBE¿ WERE NOT CONFIRMED IN THE TWO RETURNED DEVICES, AS THE PRODUCTS PREFORMED AS INTENDED PER THE INSTRUCTIONS FOR USE (IFU). THE REPORTED ¿SEALANT FAILURE TO DEPLOY - ADVANCER TUBE¿ COULD NOT BE CONFIRMED IN THE OTHER PRODUCTS, AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL FACTORS, SUCH AS AN INCOMPLETE ENGAGEMENT OF THE ADVANCER TUBE DURING THE PROCEDURE, MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IT SHOULD BE NOTED THAT IF THE SHUTTLE IS NOT ADVANCED UNTIL THE ADVANCER TUBE IS ENGAGED TO THE PROXIMAL TAMP LOCK, THIS WILL CAUSE THE ADVANCER TUBE AND SEALANT TO FOLLOW THE SHUTTLE CARTRIDGE BACK OUT OF THE TISSUE TRACT DURING THE RETRACTION STEP, RESULTING IN THE DEVICE FAILING TO DEPLOY. ACCORDING TO THE INSTRUCTIONS FOR USE WHICH IS NOT INTENDED AS A MITIGATION OF RISK, USERS ARE INSTRUCTED NOT TO USE THE DEVICE IF IT IS DAMAGED. 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, THE TAMP TUBE OF FIVE 5F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) GOT STUCK IN THE HOUSING. NO INJURY WAS REPORTED TO THE PATIENT. THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924514 MYNXGRIP VASCULAR CLOSURE DEVICE 5F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA N/A UNK 10862028000403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown