Device evaluated by mfr: the device was returned for analysis.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The catheter shaft showed damage running from 93cm from the tip to 96cm from the tip, as if the catheter was coming unraveled.A functional test was performed.The pump was placed into the ultra drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy mode.The device stayed within the expected range of the product, with an average pressure of 10.839 kpsi.During functional testing, the shaft leak was confirmed, and measured to be at the shaft damage.Review of the shaft under microscope revealed that the kink and damage at the location caused a puncture in the polymer, which resulted in the leak.
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