As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured.There was on reported patient injury.Additional information was requested but not provided.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 and the procedural sheath were not returned for evaluation.The stopcock was found opened.The sealant was found in its manufactured position fully covered by the sealant sleeves.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.Per functional analysis, an inflation/deflation test was performed per the mynx control instructions for use (ifu).The results revealed a leak in the balloon of the returned device.Per microscopic analysis, visual inspection at high magnification showed a longitudinal tear in the balloon of the returned device.In addition, the sealant was found in its manufactured position fully covered by the sealant sleeves.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 (although not returned) 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 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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