As reported, the balloon of a 5f mynx control vascular closure device (vcd) burst, so it was not used.There was no reported patient injury.The device was used in a transfemoral cerebral angioplasty (tfca) procedure.Multiple attempts to obtain additional information were made without success.A non-sterile mynx control vascular closure device 5f along with the syringe involved in the reported complaint were returned for the investigation.Visual inspection of the received device showed that the button 1 was fully depressed while button 2 was not depressed, and the stopcock was found closed.The sealant was not present in the device, and a non-cordis catheter sheath introducer (csi) related to the complaint was returned attached to the device.Additionally, the device showed exposure to blood.No other anomalies were observed during analysis.The balloon was tested for an inflation/deflation functional analysis.During this analysis, it was observed that a longitudinal tear was present on the balloon body, the present tear resulted in a leak condition that was observed during the inflation of the balloon.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the longitudinal tear found could not be conclusively determined during analysis.Based on the limited information available for review and product analysis, it is not possible to determine what factors may have contributed to the loss of pressure reported.However, prepping/handling factors, access site vessel characteristics (although not reported) and/or concomitant device factors most likely contributed to the reported event since excessive force, a calcified vessel, and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon.According to the instructions for use (ifu), which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ 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, the device preparation states, "inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and the syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate." neither the product analysis, nor the information available for review suggest that the reported failure 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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