As reported, two 6f/7f mynxgrip vascular closure devices (vcd) had balloons that would not inflate.There was no reported patient injury.The account pulled the remaining seven (7) mynxgrip devices in that box off the shelf for concerns that the integrity of the polyethylene glycol (peg) may be deteriorated.Additional information was requested but not provided.A non-sterile mynxgrip vascular closure device 6f/7f involved in the reported complaint was returned for investigation.Additionally, five (5) sterile devices from the same lot were returned for evaluation in their original sealed package, but not in a controlled-temperature condition.Per visual inspection of the non-sterile device, it showed that the shuttle was engaged to the black handle with the stopcock opened.The advancer tube was observed to have remained in its manufactured position, and the sealant was observed exposed.The syringe was received connected to the device and procedural sheath was not returned with the device.In addition, the balloon was received fully deflated.For the sterile samples, they were visual inspected for anomalies/damages, and no anomalies/damages were observed on the returned devices.Per dimensional analysis, for the five sterile units received, inflation/deflation tests were performed on the balloon of the returned devices, and pressure was maintained with proper functioning of the inflation indicator per the mynx grip instructions for use (ifu).The inflated balloon diameter was verified and noted to be within specification.Per functional analysis, leak testing was performed on the balloon of the non-sterile returned device.The results revealed a leak in the balloon.In addition, the inflation/deflation test was performed on the balloon of the five (5) sterile devices, and pressure was maintained with proper functioning of the inflation indicator.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the non-sterile returned device.In addition, for the five (5) sterile devices presented no leaks or damages in the balloon.The reported events of ¿balloon-inflation difficulty¿ were confirmed through analysis of the returned devices due to the leak found in the balloons that prevented inflation.Therefore, the additional condition of ¿balloon-balloon loss of pressure¿ was found due to the leaks.However, the exact cause of the reported leaks found in the balloons could not be conclusively determined during analysis.Based on the limited information available for review and product analyses, access site vessel characteristics (which was not provided) and/or concomitant device factors (although not returned) likely contributed to the issues found since this type of damage to the balloon can occur when the balloon comes into contact with calcification and/or other procedural devices (such as a damaged procedural sheath, stent or vascular graft), especially since there were no issues noted with the sterile devices received.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.The ifu states, ¿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, users are instructed to discard the device if the balloon does not maintain pressure.As warned in the ifu, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ neither the product analyses, nor the information available for review suggest that the failures noted could be related to the design or manufacturing process of the units.Therefore, no corrective/preventative actions will be taken at this time.
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As reported, two 6/7f mynxgrip vascular closure devices (vcd) had balloons that would not inflate.There was no reported patient injury.The account pulled the remaining mynxgrip devices in that box off the shelf for concerns that the integrity of the peg may be deteriorated.The device was not used in the patient because the balloon was tested before it entered the patient.Additional information was requested but not provided.The were not returned for evaluation as previously expected.Addendum: on product evaluation, a longitudinal tear was found in the balloon of each returned device.
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