As reported, "the end of the sheath" of a 6f/7f mynx control vascular closure device (vcd) was split and therefore, it could not insert into the 6f non cordis sheath.The device was not used in the patient and the procedure was completed with another 6f/7f mynx control.There was no reported patient injury.There was no damage to the packaging.The user is trained to the device.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 both button 1 and button 2 were not depressed.The procedural sheath was not returned for evaluation and the syringe was received separated from the device.The stopcock was observed opened, and the balloon was found fully deflated.The sealant was found exposed from the sealant sleeves, which were observed to have be severely kinked/bent outward as received with no cracks observed on it.The device was inspected for damages/anomalies that may have contributed to the reported failure, and no damages/anomalies were observed on the returned device.A dimensional test was not performed on the returned device due to the damages of the sealant outer 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be depressed to deploy the sealant with no resistance felt.Button 2 was also depressed, and the balloon was completely withdrawn into the tamp tube.No issues were noted with respect to button 1 and 2 deployment during the device failure investigation.Per microscopic analysis, visual inspection at high magnification revealed that the sealant was found exposed from the sealant sleeves due to the severely kinked/bent outward condition as received.However, no cracks were observed on it.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a severely kinked/bent 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 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, 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.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 end of the sheath" of a 6f/7f mynx control vascular closure device (vcd) was split and therefore, it could not insert into the 6f non cordis sheath.The device was not used in the patient and the procedure was completed with another 6f/7f mynx control.There was no reported patient injury.There was no damage to the packaging.The user is trained to the device.The device will be returned for evaluation.Addendum: product evaluation demonstrates that the sealant was found exposed from the sealant sleeves.
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