The device was returned to inari and subjected to visual inspection.The findings confirmed that the dilator hub had been cut by the physician as described, but there were no anomalies or device defects observed.The condition of the returned device precluded further analysis (e.G., dimensional analysis, performance testing).The device history records were reviewed for this manufacturing lot and there were no anomalies, discrepancies, or non-conformances.The root cause of the event was believed to be related to use error where the device was deployed in a vessel that was smaller than the manufacturer's recommendations.The device labeling lists the following contraindication: "not intended for use in vessels < 6 mm." (b)(4).
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A patient required intervention to treat bilateral deep vein thrombosis (dvt) after previous angiojet and 24-hour tpa drip using ekos device.The physician successfully treated the patient's left dvt by aspiration with an 8 fr catheter.On the right side, the physician inserted the inari clottriever sheath, model 50-101, in the patient's right popliteal vein measuring 4-5 mm in diameter via venogram.After successfully deploying the funnel by advancing the dilator, the physician was unable to withdraw the dilator through the clottriever sheath.The physician retracted both the clottriever sheath and dilator until the sheath exited the vessel, but the dilator remained in the vessel.The physician intervened to cut the dilator hub, then withdrew the clottriever sheath from the access site.Using a 14 fr sheath, the physician was able to successfully remove the dilator from the patient without damaging the vessel.
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