Complaint conclusion: as reported, the sealant sleeve of a 5f mynx control vascular closure device (vcd) stuck the edges of the 5f non-cordis sheath hub, causing it to split while the user attempted to advance the device through the sheath.As a result, it became difficult to fully insert the device.Hemostasis was achieved by another unknown mynx device.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).The sealant sleeves were inspected prior to use.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in a diagnostic procedure with a retrograde approach.The deployer is mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd 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, and the stopcock was found opened.The syringe and the procedural sheath were not returned.The sealant was found partially exposed from the sealant sleeves, which were observed to have been severely kinked/bent outward as received; however, no cracks were observed on it.In addition, it was noted that there was crystallized residuals in the balloon.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 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.Button #2 was not able to be fully depressed since it was noted that on the balloon was crystallized residual, which may have contributed to the balloon was not completely withdrawing into the tube.Per microscopic analysis, visual inspection at high magnification revealed that the sealant was found partially exposed from the sealant sleeves due it was observed to have been severely kinked/bent outward as received, however no cracks were observed on it.In addition, it was noted that there was crystallized residual in the balloon.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a severely kinked condition of the sleeves was noted.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature due to the exposed sealant from the kinked sleeves.The exact cause of the observed conditions could not be conclusively determined during analysis.Based on the 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 as there was mild tortuosity with the access vessel), and/or the condition of the sheath (although not returned) possibly contributed to the damaged condition of the sealant sleeves, the impedance experienced during insertion, 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.Regarding the issues experienced during functional analysis of button 2, the inability to fully retract the balloon into the tamp tube and fully depress button 2 was very likely due to the crystallized solution within the deflated balloon.However, this condition was unlikely to have occurred during use of the device by the customer as the saline solution would not likely have been crystallized when attempting to use this mechanism.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, the sealant sleeve of a 5f mynx control vascular closure device (vcd) stuck the edges of the 5f non-cordis sheath hub, causing it to split while the user attempted to advance the device through the 5f non-cordis sheath.As a result, it became difficult to fully insert the device.Hemostasis was achieved by another unknown mynx device.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).The sealant sleeves were inspected prior to use.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in a diagnostic procedure with a retrograde approach.The deployer is mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: per product evaluation the sealant was found partially exposed from the sealant sleeves due it was observed to have been severely kinked/bent outward as received, however no cracks were observed on it.
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