As reported, there was a "sealant problem" with a 5f mynx control vascular closure device (vcd).There was no reported patient injury.Additional information was requested but not provided.A non-sterile ¿mynx control vascular closure device 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed with the stopcock opened.No damage was observed to the atraumatic tip of the returned device.The sealant was noted swelled from exposure to blood and exposed from the sealant sleeves, which were observed severely kinked/bent outward as received; however, no cracks were observed on it.No damages were noted to the sealant.The syringe was received separated from the device, and the procedure sheath was not returned for evaluation.Dimensional analysis could not be performed on the returned device due to the severely kinked/bent outward condition of the sealant sleeve assembly.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control instructions for use (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, and the returned device performed as intended per the mynx control ifu.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.Per microscopic analysis, visual inspection at high magnification showed that the sealant was noted to be swelled from exposure to blood and exposed from the sealant sleeves due to the severely kinked/bent outward condition observed as received with no cracks on it.The reported event of ¿sealant-damaged¿ was not confirmed as there were no damages noted to the sealant; however, the sealant was found to be swelled due to exposure to blood and the sealant sleeves were noted to be severely kinked/bent.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the kinked/bent sealant sleeves.The exact cause of the observed condition could not be conclusively determined during analysis.Based on the limited 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 (such as excessive force during insertion and/or incorrect insertion angle), and/or the condition of the sheath (although not returned) possibly contributed to the kinked condition of the sealant sleeves, and the subsequent premature exposure/swelling 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 sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The outer sleeve is assembled with 2 side slit overlapping outer sleeves.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 instructions for use (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 observed could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
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