After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h11.Complaint conclusion: as reported, the housing tube around the sealant area of a 6f/7f mynx control vascular closure device (vcd) split prior to entering completely into the working non-cordis sheath.The device was removed and a second device was opened and entered into the working non-cordis sheath with the exact same result.The sealant was exposed on both devices.The user was trained to the device.The second device was removed and third device with a different lot number was opened and used with no difficulties.The patient did great with no abnormalities or difficulties; there was no patient injury reported.The device was used by the interventional radiologist to close the artery after an interventional procedure.The sheath was flushed and adequate flush was maintained throughout the procedure.(b)(4): the first device was not returned for evaluation as it was discarded.The reported events of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ and ¿mynx control system-deployment difficulty-premature¿ could not to be confirmed for the first reported device as it was not returned for analysis.Also, the reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned second device since there were no frayed/split/torn conditions noted; however, a kinked/bent condition of the sleeves was noted.However, the reported event of ¿mynx control system-deployment difficulty-premature¿¿¿ was confirmed through analysis of the returned second device due to the exposed sealant from the kinked 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, it is difficult to determine what factors may have contributed to the issue experienced.However, procedural/handling factors (such as using excessive force during insertion into the sheath and/or using an incorrect insertion angle) 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.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.¿ neither the product analysis, nor the information available for review suggest that the failures could be related to the design or manufacturing process of the units.Therefore, no corrective/preventative actions will be taken at this time.
|