As reported, the sealant sleeves of the 5f mynx control vascular closure device (vcd) were split, preventing the operator from inserting it into the sheath, and the sealant was exposed.Hemostasis was achieved by manual pressure.There was no reported patient injury.The operator in charge of the device was certified in handling mynx, and there was no evident damage to the device prior to unpacking.The device had been stored and prepared in accordance with the instructions for use (ifu).The sheath was not flushed prior to attempting to insert the mynx.The device will be returned for evaluation.
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Complaint conclusion: as reported, the sealant sleeves of the 5f mynx control vascular closure device (vcd) were split, preventing the operator from inserting it into the sheath, and the sealant was exposed.Hemostasis was achieved by manual pressure.There was no reported patient injury.The operator in charge of the device was certified in handling the mynx, and there was no evident damage to the device prior to unpacking.The device had been stored and prepared in accordance with the instructions for use (ifu).The sheath was not flushed prior to attempting to insert the mynx.A non-sterile ¿mynx control vcd, 5f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that button #1 and button #2 were not depressed.The procedural sheath was not returned.The syringe was connected to the device, and the stopcock is set in the open position.The balloon was not inflated.The sealant was in its manufactured position, saturated in blood and fully covered by the sleeves.The sealant sleeves presented a kinked condition.The atraumatic tip did not present any damages or anomalies.No other outstanding details were noticed.The dimensional analysis of the slit length on the outer sleeve was not verified to the severe outward kinked condition of the sealant sleeve assembly.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control ifu.The tension indicator was aligned manually, and buttons 1 and button 2 were able to be depressed to deploy the sealant and withdraw the balloon with no resistance felt.No issues were noted with respect to both buttons 1 and 2 deployment during the device failure investigation.The returned device performed as intended per the mynx control ifu.The reported events of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ and ¿mynx control system-deployment difficulty-premature¿ were not confirmed through analysis of the returned device since there were no frayed/split/torn condition noted to the sleeves and the sealant was fully contained within the device.The cause of the issue experienced by the customer could not be conclusively determined during analysis.Based on the information available for review and the product analysis, it is difficult to determine what factors may have contributed to the failure experienced.However, handling factors are likely contributed to the kinked/bent condition noted of the sleeves.It should be noted that the slits in the sealant sleeve assembly are not a product defect.The mynx control device is manufactured with the sealant sleeve assembly at the distal end of the catheter cartridge tubing.The sealant sleeve assembly is assembled with 2 side slit overlapping sleeves.The slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the sealant sleeve assembly and is protected by the sealant sleeve assembly from being exposed prematurely.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 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 issue experienced by the customer 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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