A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded and not returned to the manufacturer for evaluation; therefore, the alleged product issue cannot be confirmed.The onyx instruction for use (ifu) identifies delivery catheter removal difficulty as potential complications associated with use of the device.Warnings include: premature solidification of onyx may occur if micro catheter luer contacts saline, blood or contrast of any amount.Do not exceed 0.3 ml/min injection rate.Animal studies have shown that rapid injection of dmso into the vasculature may lead to vasospasm and/or angionecrosis.Do not allow more than 1 cm of onyx to reflux back over catheter tip.Excessive onyx reflux may result in difficult catheter removal.Stop injection if increased resistance to onyx injection is observed.If increased resistance occurs, determine the cause (e.G., onyx occlusion in catheter lumen) and replace the catheter.Do not attempt to clear or overcome resistance by applying increased injection pressure, as use of excessive pressure may result in catheter rupture and embolization of unintended areas.Do not interrupt onyx injection for longer than two minutes prior to re-injection.Solidification of onyx may occur at the catheter tip resulting in catheter occlusion, and use of excessive pressure to clear the catheter may result in catheter rupture.
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