As reported, when using a 5f mynx control vascular closure device (vcd), the sealant protection tip remains damaged.There was no reported patient injury.The device was used in a transfemoral cerebral angiogram (tfca).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 closed.No damage was observed in the atraumatic tip of the returned device.The sealant was noted to be swelled from exposure to blood and exposed from the sealant sleeves, which were observed to be severely kinked/bent outward as received, however no cracks were observed on it.The syringe was received connected to the device and the procedural sheath was not returned for evaluation.Dimensional analysis could not be performed on the returned device due to the severely kinked/bent sealant sleeve assembly condition.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.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 swelled from exposure to blood and exposed from the sealant sleeves due to their severely kinked/bent outward condition with no cracks observed.The reported event of ¿sealant sleeves (cartridge assembly)-damaged¿ was confirmed through analysis of the returned device as the sealant sleeve assembly had a severely kinked/bent condition observed as ¿sealant sleeves (cartridge assembly)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 damaged sleeves.The exact cause of the observed conditions 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 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 assembly 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 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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As reported, when using a 5f mynx control vascular closure device (vcd), the sealant protection tip remains damaged.There was no reported patient injury.The device was used in a transfemoral cerebral angiogram.Additional information was requested but not provided.The device is being returned for evaluation.Addendum: product evaluation shows the sealant was exposed from the sealant sleeves as the sealant sleeves were kinked, bent.
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