As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The device was used in a diagnostic procedure using a retrograde approach.The deployer was mynx certified.The vcd was used with a 5f non-cordis sheath.The device was stored and prepped per the instructions for use (ifu).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 or equal to 5mm in diameter.There was little vessel tortuosity.There was no presence of pvd / calcium in the vicinity of the puncture site.The balloon lost pressure while inside the patient.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The device will be returned for evaluation.
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Complaint conclusion: as reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for less than 30 minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The device was used in a diagnostic procedure using a retrograde approach.The deployer was mynx certified.The vcd was used with a 5f non-cordis sheath.The femoral arterys 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 or equal to 5mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease (pvd) / calcium in the vicinity of the puncture site.The balloon lost pressure while inside the patient.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.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 received for evaluation.The stopcock was observed opened, and the balloon was found fully deflated.In addition, the sealant was found in its manufactured position fully covered by the sealant sleeves, and the sealant was not exposed to blood.In addition, no damages were observed to sealant sleeves assembly.Per functional analysis, an inflation/deflation test was conducted in accordance with the mynx control ifu, and a leak in the balloon of the returned device was exposed.Per microscopic analysis, upon visual examination at high magnification, a longitudinal tear was detected in the balloon of the returned device.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 information available for review and product analysis, it is difficult to determine what factors may have contributed to the loss of pressure reported.However, access site vessel characteristics (although reported that there was no presence of pvd/calcium in the vicinity of the puncture site) and/or concomitant device factors (although not returned) most likely contributed to the reported event since a calcified vessel, and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause this type of 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 to discard the device if the balloon does not maintain pressure.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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