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As reported, the balloon of a 5f mynx control vascular closure device (vcd) did not deflate.When it was attempted to deflate more, the tip of the device split open.The balloon inflated okay, but when it was deflated, the balloon it did not deflate properly or all the way.The split was at the level of the balloon.A new unknown device was used to complete the procedure.There was no reported patient injury or tissue damage.The device was used in an angiogram for closure of the ileo-femoral artery.The procedure time was extended due to the failure of the device.There was no additional medical intervention required.The user is trained to the device.The device was opened in a sterile field.The device and packaging was inspected prior to use.The device was stored and prepped per the instructions for use (ifu).The device will be returned for evaluation.
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As reported, the balloon of a 5f mynx control vascular closure device (vcd) did not deflate.When it was attempted to deflate more, the tip of the device split open.The balloon inflated okay, but when it was deflated, the balloon did not deflate properly or all the way.The split was at the level of the balloon.A new unknown device was used to complete the procedure.There was no reported patient injury or tissue damage.The device was used in an angiogram for closure of the ileo-femoral artery.The procedure time was extended due to the failure of the device.There was no additional medical intervention required.The user was trained to the device.The device was opened in a sterile field.The device and packaging were inspected prior to use.The device was stored and prepped per the instructions for use (ifu).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 syringe was received separated from the device, and the procedural sheath was not received for evaluation.The stopcock was observed opened and the balloon was found fully deflated.The sealant was found exposed from the sealant sleeves and exposed to blood.The sealant sleeves were observed to have been kinked/bent.Per functional analysis, an inflation/deflation test was performed on the balloon of the returned device, and during this evaluation, the balloon was fully inflated, and pressure was maintained.The balloon was able to be inflated/deflated with proper functioning of the inflation indicator as intended per the mynx control ifu.No damages were observed to the balloon.In addition, 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 balloon of the returned device maintained the pressure and could be fully deflated.In addition, the sealant was found exposed from the sealant sleeves and exposed to blood.The sealant sleeves were observed to have been kinked/bent.The reported events of "balloon-deflation difficulty" and "balloon-balloon loss of pressure" were not confirmed through analysis of the returned device since the balloon passed functional analysis.However, an additional 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 reported incident and the observed condition of the device could not be conclusively determined during analysis of the returned device.Based on the limited information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issue experienced since there was no rupture or deflation difficulty noted.However, balloon prep (such as not removing all air from the device), contrast media factors (such as using a high contrast ratio) and/or handling factors are possible.Regarding the kinked/bent sleeves and the premature exposure of the sealant, procedural/handling factors (such as using excessive force during insertion), access site vessel characteristics (although not reported), and/or the condition of the sheath (although not returned) possibly contributed to the damaged condition of the sealant sleeves, 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.However, as this condition was not reported by the customer, it is unknown if this received condition occurred due to manipulations after the procedure.Although not intended as a mitigation, the ifu instructs that, "the balloon may be prepped with a diluted contrast solution (50% contrast/50% saline), in place of 100% saline in order to visualize the balloon while pulling back to the arteriotomy and to ensure that the balloon properly abuts the arteriotomy.Do not use 100% contrast solution as this will impact balloon inflation/deflation." the ifu also instructs users to purge the device of air by drawing vacuum with 2-3 ml of sterile saline prior to use.It also states to check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.Failure to purge the device of air during the prep phase and/or excessive tension applied to the catheter during pullback can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and cause the balloon to be pulled through the arteriotomy, which can be mistaken as a balloon rupture.Also included in the ifu, step 3: remove device, "retract syringe plunger to lock position.Apply light fingertip compression proximal to the insertion site, then lightly grasp the advancer tube at skin with thumb and forefinger and realign with the tissue tract.Open the stopcock to deflate the balloon.To ensure complete balloon deflation, wait until air bubbles and fluid have stopped moving through the inflation tubing." it should be noted that viscous contrast solution might cause difficulties when inflating/deflating the balloon and/or delay the balloon¿s inflation/deflation time.Additionally, as warned in the ifu, "do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened." neither the product analysis, nor the information available for review suggest that the reported 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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