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As reported, a 5f mynx control vascular closure device (vcd) became stuck in the sheath as they tried to put it through.Hemostasis was achieved by manual compression and the patient recovered.There was no reported patient injury.The event date and lot number were requested; however, not provided.The femoral artery¿s suitability was verified on angiography including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.The sheath was not kinked/bent upon removal and there was no visible bent/damage in the distal end of the balloon shaft after removal.The deployer's was mynx certified.The device was returned for evaluation.According to the product evaluation, the sealant was found partially exposed from the sealant sleeves and also kinked.
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As reported, a 5f mynx control vascular closure device (vcd) became stuck in the sheath as they tried to put it through.Hemostasis was achieved by manual compression and the patient recovered.There was no reported patient injury.The event date and lot number were requested; however, not provided.The femoral artery¿s suitability was verified on angiography including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.The sheath was not kinked/bent upon removal and there was no visible bent/damage in the distal end of the balloon shaft after removal.The deployer was mynx certified.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.The syringe was received connected to the device and an unknown procedural sheath was locked on to the sheath catch.Blood was noted in the procedure sheath, and no damages were observed on it.The stopcock was observed open.In addition, the balloon was found fully deflated, and the sealant was found partially exposed from the sealant sleeves, which were observed to have been kinked/bent.Per functional analysis, the insertion/withdrawal test on the returned product was performed with an applicable lab sample sheath introducer and with the unknown procedural sheath received.The device was able to be inserted/advanced through the lab sample sheath and the unknown procedural sheath without issue during the device failure investigation.The lab sample sheath and the unknown procedural sheath received were also able to be withdrawn without issue.The returned device performed as intended per the mynx control instructions for use (ifu).Additionally, 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 able to be fully depressed, and no issues were noted with respect to button 2.The returned device performed as intended per the mynx control ifu.Per microscopic analysis, visual inspection at high magnification showed that the sealant was found partially exposed from the sealant sleeves, which were observed to have been kinked/bent.The reported event of ¿mynx control system-impeded¿ was not confirmed through analysis of the returned device since the device passed functional analysis with the insertion/withdraw test on both the procedural sheath and a lab sample sheath.However, an additional condition of ¿mynx control system-deployment difficulty-premature¿ was noted due to the partially exposed sealant from kinked/bent sealant sleeves.The exact cause of the issues experienced by the customer could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is not possible to determine what factors may have contributed to the partially exposed sealant and kinked/bent sealant sleeves noted during visual analysis.However, procedural/handling factors (such as using excessive force during insertion into the sheath and/or using an incorrect insertion angle) are likely since the device could be inserted/withdrawn with no resistance felt during functional analysis.It should be noted that the mynx control device is manufactured with slits 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 the 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 reported failure and noted condition 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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