As reported, the balloon of the 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography or venography including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was used in diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.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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Complaint conclusion: as reported, the balloon of the 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.The mynx vcd was used in diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd, 5f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that both button #1 and button #2 were not depressed, and the syringe was attached to the device with the stopcock set in the closed position.The procedural sheath was not returned for analysis.The sealant remained in its manufactured position fully covered by the sleeves.The balloon was not inflated, and the atraumatic tip did not present any damages or anomalies.No other outstanding details were noticed.Per functional analysis, an inflation/deflation test was performed by injecting water into the returned device according to the ifu.The balloon inflated as expected and the inflation indicator popped up.No anomalies were observed.The reported event of ¿balloon-balloon loss of pressure¿ was not confirmed through analysis of the returned device since the balloon passed functional analysis.The exact cause of the reported incident could not be conclusively determined during analysis of the returned device.Based on the information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issue experienced since there was no rupture noted.However, balloon prep and/or handling factors are possible.Although not intended as a mitigation, the mynx control ifu instructs users to purge the device of air by drawing vacuum with 2-3 ml of sterile saline prior to use.It also states to check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.Failure to purge the device of air during the prep phase and/or excessive tension applied to the catheter during pullback can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and cause the balloon to be pulled through the arteriotomy, which can be mistaken as a balloon rupture.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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