Device analysis by mfr: the returned product consisted of a direxion microcatheter.The tip, inner/outer shaft, and hub/strain relief were microscopically and visually inspected.A test.018 wire was attempted to be advanced through the device, but was unable, therefore the device was soaked in the water bath for 5 days.When the device was removed from the bath, the test wire was attempted again and was unable to advance through the entire device.The wire advanced through the proximal end of the device stopping 3.2cm from the distal tip.The outer nitinol shaft is damaged and fractured starting 3.2cm from the distal tip.The inner polymer shaft has become damaged as well due to being used during a procedure and from the nitinol shaft damage.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
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Reportable based on device analysis completed 08dec2020: it was reported there was an occlusion in the catheter.A direxion infusion catheter was selected for use.100 microns of oncozene microspheres were hand injected through the catheter.However, the microspheres clumped together and occluded the catheter 20cm from the catheter tip.A wire was used to help the occlusion but they could not inject more microspheres.However, the product investigation revealed a outer shaft fracture 3.2cm from the tip.
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