H6: device code: 2017 clarifier: incorrect prep.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.It should be noted that the omnilink elite instructions for use (ifu) states: prepare an inflation device syringe with diluted contrast medium.Attach an inflation device syringe to the stopcock; attach to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device syringe of all air.Repeat steps until all air is expelled.In this case, it is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported leak splash cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.
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It was reported that the procedure was to treat a common iliac artery lesion.A 8.0×19mm omnilink elite balloon expandable stent system (bes) was delivered to the target lesion; however, when air aspiration was performed, more air was aspirated than usual.It was suspected that the bes could have a leak; therefore, the bes was removed.Another omnilink elite was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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