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As reported, button one of a 5f mynx control vascular closure device (vcd) was not pressed during the procedure.Therefore, the product wasn¿t available.Manual compression was performed for 20 minutes.There was no reported patient injury.The device was prepared and used as per the instructions for use (ifu).The intended procedure was a percutaneous coronary intervention (pci) using a retrograde approach.There were no visible signs of device/package damage prior to use.The device storage temperature did not exceed 25 °c.The device and the other devices used with the complaint product were re-sterilized.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.A non-cordis sheath was used.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 5mm in diameter.The puncture site did not have visible calcium/plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.Fingertip compression was maintained on the skin during removal of the device.There were no issues noted during balloon retraction/button two step.There was no issue with button two since the device was not deployed because of malfunction of button one.Operator didn¿t pressed button two because there was no need to press button two to retract the device where the device didn¿t even deploy.The patient did not have a thin body habitus nor shallow vessel depth.The balloon was fully deflated.There was no resistance noted during use of the device.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.An unknown procedural sheath was locked onto the sheath catch and blood was noted in the procedural sheath.The syringe was received connected to the device with the stopcock found opened.The balloon was observed fully deflated.The sealant sleeve assembly was observed to have been severely kinked/bent outward as received; however, no cracks were observed on it.Additionally, the sealant sleeves were not fully covering the sealant, which was exposed and swelled from exposure to blood.Per functional analysis, an inflation/deflation test was simulated, and there was a leak found in the balloon of the device.In addition, a simulated deployment test was performed on the returned device per the mynx control ifu, and button 1 was able to be fully depressed and locked in place with some resistance felt.It was revealed that the sealant was exposed to blood, which caused the resistance felt when attempting to depress button 1.However, button 2 was not completely depressed and locked in place since the balloon could not be retracted completely into the tamp tube due to the leak condition.Per microscopic analysis, visual inspection at high magnification showed that after the functional test the balloon of the returned device was not fully retracted into the tamp tube due a tear found in the balloon.In addition, the microscopic analysis revealed the tear in the balloon of the returned device was longitudinal, and the sealant sleeve assembly was observed to have been severely kinked/bent outward as received with no cracks observed on it.Additionally, the sealant sleeves were not fully covering the sealant, which was exposed and swelled from exposure to blood.The product history record (phr) review of lot f2224402 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿button #1-frozen/locked¿ was not confirmed through analysis of the returned device since it passed functional analysis.However, additional conditions were noted in the returned device of ¿balloon-balloon loss of pressure¿ due to the leak and tear found on the balloon, and ¿mynx control system-deployment difficulty-premature¿ as an exposure of the sealant was observed due to the condition of the sealant sleeves noted.The exact cause of the reported button issue, the longitudinal tear found in the balloon and the condition of the exposed sealant 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 issues.However, off label use (the device was resterilized) may have contributed to conditions noted since this can result in the compromise of the structural integrity of the device and/or lead to device failure.Additionally, access site vessel characteristics (although the puncture site did not have visible calcium/plaque.) and/or concomitant device factors may have contributed to the longitudinal tear found since this type of damage to the balloon can occur when the balloon comes into contact with calcification and/or other procedural devices.Also, if this leakage occurred during device use, this could prevent proper tension application, which would result in the inability to depress button 1.Additionally, these factors could also contribute to the premature exposure of the sealant from the sealant sleeves.It should be noted that the mynx control device is manufactured with a slit at the end of the catheter cartridge tubing.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The outer sleeve is assembled with 2 side slit overlapping outer sleeves.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, that could cause the sealant to be exposed/swollen prematurely.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 of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.As warned in the ifu, ¿do not reuse or resterilize.The mynx control vcd is for single use only.The catheter is loaded with a single hydrogel sealant.Reuse of the device would result in no delivery of hydrogel sealant.¿ usage of the product other than that indicated in the product's ifu may involve additional risks/issues not described in the labeling.The ifu also warns, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ per the procedural steps within the ifu, ¿grasp the device handle and align the device with the tissue tract.Pull gently to retract the device until the black line in the tension indicator window aligns with the markers on the side, indicating the balloon is abutting the arteriotomy with the correct amount of tension.While maintaining tension press button #1 until it is fully aligned with the handle, and the clock symbol is visible in the tension indicator window.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram: common femoral artery single wall puncture, evidence of adequate flow, no evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.Neither the phr review, nor the product analysis suggest that the issues experienced 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, button one of a 5f mynx control vascular closure device (vcd) was not pressed during the procedure.Therefore, the product wasn¿t available.Manual compression was performed for 20 minutes.There was no reported patient injury.The device was prepared and used as per the instructions for use (ifu).The intended procedure was percutaneous coronary intervention (pci) using a retrograde approach.There were no visible signs of device/package damage prior to use.The device storage temperature did not exceed 25 °c.The device and the other devices used with the complaint product were re-sterilized.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.A non cordis sheath was used.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 5mm in diameter.The puncture site did not have visible calcium/plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.Fingertip compression was maintained on the skin during removal of the device.There were no issues noted during balloon retraction/button two step.There was no issue with button two since the device was not deployed because of malfunction of button one.Operator didn¿t pressed button two because there was no need to press button two to retract the device where the device didn¿t even deploy.The patient did not have a thin body habitus nor shallow vessel depth.The balloon was fully deflated.There was no resistance noted during use of the device.The device will be returned for evaluation.Addendum: product analysis demonstrates the sealant sleeves were not fully covering the sealant, exposed, and swelled from exposure to blood.In addition, a longitudinal tear in the balloon was found.
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