As reported, when a 5f mynx control vascular closure device (vcd) was taken out of the box, it was already deployed.A second mynx device was used a deployed successfully.There was no patient injury.The device was stored and prepped according to the instructions for use (ifu).The deployer was certified in the use of the mynx device.The sealant sleeves (cartridge assembly) were not out of position.There were no damages noted to the sealant sleeves (cartridge assembly).The device was stored and prepped per the instructions for use (ifu).The device was not used in the patient.The device is being returned for evaluation.
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As reported, when a 5f mynx control vascular closure device (vcd) was taken out of the box, it was already deployed.A second mynx device was used a deployed successfully.There was no patient injury.The device was stored and prepped according to the instructions for use (ifu).The deployer was certified in the use of the mynx device.The sealant sleeves (cartridge assembly) were not out of position.There were no damages noted to the sealant sleeves (cartridge assembly).The device was stored and prepped per the instructions for use (ifu).The device was not used in the patient.A non-sterile ¿mynx control vcd, 5f¿ 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, and the stopcock was observed opened.In addition, the balloon was found fully deflated.The sealant was found exposed from the sealant sleeves.The sealant sleeves were observed to have been kinked/bent as received; however, no cracks were observed on it.The device was inspected for other 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 to the sealant outer sleeve assembly as received.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be depressed to deploy the sealant with no resistance felt.Button 2 was also depressed, and the balloon was completely withdrawn into the tamp tube.No issues were noted with respect to button 1 and 2 deployment during the device failure investigation.Per microscopic analysis, visual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 kinked/bent condition observed as received.However, no cracks were observed on it.The reported event of ¿mynx control system-deployment difficulty-premature¿ was confirmed due to the exposed sealant from the 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 not possible to determine what factors may have contributed to the reported premature deployment/exposure of the sealant after removal from the box.However, prepping/handling factors are likely since the exposed sealant condition was due to the kinked/bent conditions of the sealant sleeves observed with the returned device.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.However, as the user reported that the sealant sleeves were not damaged, it is unknown if this condition occurred during the handling of the device, or after the procedure.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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