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As reported, while attempting to advance a 5f mynx control vascular closure device (vcd) through the sheath, the outer sleeve struck the edges of an unknown sheath hub, causing it to split.As a result, it became difficult to fully insert the device.Hemostasis was achieved with another mynx device.There was no reported patient injury.The device was stored and prepared according to the instructions for use (ifu).There were no visible signs of device or package damage prior to use.The device was used in a diagnostic procedure using a retrograde approach.The deployer was certified in the use of the mynx device.The device was used with a 5f non-cordis sheath.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 5mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.No excess force was applied during insertion.The device will be returned for analysis.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 and the syringe were not returned, and the stopcock was observed opened.In addition, the balloon was found fully deflated, however, it was noted that there were crystallized residuals on it.The sealant was found exposed to blood and partially exposed from the sealant sleeves, which were observed to have been severely kinked/bent outward as received.However, no cracks were observed on it.The device was inspected for damages/anomalies that may have contributed to the reported failure and no damages/anomalies were observed with 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 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 not able to be fully depressed since it was noted that on the balloon were crystallized residuals, which may have contributed to the balloon was not completely withdrawing into the tube.Per microscopic analysis, visual inspection at high magnification revealed a micro tear in the balloon of the returned device and crystallized residuals on it.The sealant was found exposed to blood and partially exposed from the sealant sleeves due to the severely kinked/bent outward condition observed with no cracks on it.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, the sealant sleeves were found to be severely kinked/bent.Additionally, conditions were noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the partially exposed sealant from the severely kinked/bent sleeves, ¿button #2-frozen/locked¿ due to the issue experienced during functional analysis, and ¿balloon-balloon loss of pressure¿ due to the micro tear found during microscopic analysis.The exact cause of the observed conditions could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is difficult to determine what factors may have contributed to the issue experienced by the customer.However, procedural/handling factors (although it was reported that there was no excessive force applied) and/or the condition of the sheath (although not returned) possibly contributed to the kinked/bent 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 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.Regarding the issues experienced during functional analysis of button 2, the inability to fully retract the balloon into the tamp tube and fully depress button 2 was likely due to the crystallized solution within the balloon.However, this condition was unlikely to have occurred during use of the device by the customer as the saline solution would not likely have been crystallized when attempting to use this mechanism.Also, the micro tear found on the balloon may have been due to handling factors after prep of the balloon as there were no issues reported regarding inflation of the balloon by the customer.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.¿ also included in the ifu, step 3: remove device states to ¿retract the syringe plunger to lock position.Apply light fingertip compression proximal to the insertion site and then lightly grasp the device 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.Pick up the device handle and realign with the tissue tract.Depress button #2 to pull the deflated balloon into the device.¿ 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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As reported, while attempting to advance a 5f mynx control vascular closure device (vcd) through the sheath, the outer sleeve struck the edges of an unknown sheath hub, causing it to split.As a result, it became difficult to fully insert the device.Hemostasis was achieved with another mynx device.There was no reported patient injury.The device was stored and prepared according to the instructions for use.There were no visible signs of device or package damage prior to use.The device was used in a diagnostic procedure using a retrograde approach.The deployer was certified in the use of the mynx device.The device was used with a 5f non-cordis sheath.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 5mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease or calcium in the vicinity of the puncture site.No excess force was applied during insertion.The device will be returned for analysis.Addendum: on product evaluation, visual inspection at high magnification revealed a micro tear in the balloon of the return device.The sealant was found partially exposed from the sealant sleeves and exposed to blood.Button #2was not able to be fully depressed since it was noted that on the balloon was crystallized residual fluid.
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