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As reported, the sealant sleeve of a 5f mynx control vascular closure device (vcd) was damaged.The damage to the sealant sleeve was noted after removal.Therefore, the device couldn't enter the unknown sheath and manual compression was proceeded for 20 minutes.There was no reported patient injury.The physician was mynx certified.The device was stored according to the instructions for use (ifu).The storage of the device did not exceed 25 °c.There were no anomalies noted prior to use.The mynx device was prepped according to the ifu and no difficulty was noted.The mynx device was not purged of air during prep.The mynx device was used in the patient.No unusual force was applied when the sheath was retracted.A 5f non-cordis sheath was used during the procedure.There were no kinks in the sheath after removal.There was no damage to the button.The button was not depressed at all.The tension indicator was not aligned with the markers on the handle halves before attempting to deploy.The device was not inspected for damages when removed from the package.The procedure used a retrograde approach.There was no presence of pvd / calcium in the vicinity of the puncture site.The stick location was above the femoral head.The vessel diameter was verified to be greater than or equal to 5mm.The vessel was reported to have moderate tortuosity.Additional information was requested but not received.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.
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As reported, the sealant sleeve of a 5f mynx control vascular closure device (vcd) was damaged.The damage to the sealant sleeve was noted after removal.Therefore, the device couldn't enter the unknown sheath and manual compression was proceeded for 20 minutes.There was no reported patient injury.The physician was mynx certified.The device was stored according to the instructions for use (ifu).The storage of the device did not exceed 25 °c.There were no anomalies noted prior to use.The mynx device was prepped according to the ifu and no difficulty was noted.The mynx device was not purged of air during prep.The mynx device was used in the patient.No unusual force was applied when the sheath was retracted.A 5f non-cordis sheath was used during the procedure.There were no kinks in the sheath after removal.There was no damage to the button.The button was not depressed at all.The tension indicator was not aligned with the markers on the handle halves before attempting to deploy.The device was not inspected for damages when removed from the package.The procedure used a retrograde approach.There was no presence of pvd / calcium in the vicinity of the puncture site.The stick location was above the femoral head.The vessel diameter was verified to be greater than or equal to 5mm.The vessel was reported to have moderate tortuosity.Additional information was requested but not received.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.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 the procedural sheath was not received for evaluation.The stopcock was observed open, and the balloon was found fully deflated.Additionally, the sealant was found exposed from the sealant sleeves, which were observed to have been severely kinked/bent outward as received.However, no cracks were observed on it.No damages were found with the atraumatic wire distal tip.Per functional analysis, an insertion/withdrawal test on the returned product could not be performed on the returned device due to the severely kinked/bent outward as received sealant sleeve assembly condition.However, 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.The returned device performed as intended per the mynx control ifu.Button #2 was able to be fully depressed, and no issues were noted with respect to button #2.Per microscopic analysis, visual inspection at high magnification showed that the sealant was found exposed from the sealant sleeves due to the severely kinked/bent outward condition as received; however, no cracks were observed on it.The reported events of ¿sealant sleeves (cartridge assembly)-damaged¿ and ¿mynx control system-impeded¿ were confirmed through analysis of the returned device due to the severely kinked/bent condition of the sealant sleeves noted during visual/microscopic analysis, and the inability to perform the insertion/withdrawal test during functional analysis.Also, an additional condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the damaged sleeves.The exact cause of the observed conditions could not be conclusively determined during analysis.Based on the information available for review and product analysis, procedural/handling factors (such as excessive force due to report of moderate tortuosity), and/or the condition of the sheath (although not returned and reported to have no kinks noted) may have contributed to the damaged condition of the sealant sleeves, and the subsequent premature swelling/exposure of the sealant and impedance.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 slits are designed to decrease unsheathing force and increase deployment reliability the sealant is placed right under the outer sleeve assembly and is protected from exposing 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 sheath, that 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 in 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 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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