As reported, the white tube tip of a 6f/7f mynx control vascular closure device (vcd) was damaged and did not enter the sheath when attempting to use the device.There was no reported patient injury.The vcd was used after percutaneous coronary intervention.Additional information was requested but not provided.Multiple attempts to obtain additional information were made without success.A non-sterile ¿mynx control vcd 6f 7f¿ 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, and the stopcock was found opened.The syringe and procedural sheath were not received for evaluation.The sealant sleeve assembly was observed to have been severely kinked/bent outward as received.Additionally, the sealant sleeves were not fully covering the sealant, and the sealant was found swollen from exposure to blood.A dimensional analysis test was not performed on the returned device due to the damages of the sealant sleeve assembly as received.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 revealed that the sealant sleeve assembly was observed to have been severely kinked/bent outward as received.Additionally, the sealant sleeves were not fully covering the sealant, and the sealant was found swelled from exposure to blood.The reported event of damage, which was found to be a ¿sealant sleeves (cartridge assembly)-kinked/bent¿ condition, was confirmed through analysis of the returned device as sleeves were severely kinked/bent outward as received.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the severely kinked/bent 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/bent 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 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 noted 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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