Sample evaluation: the sample was returned for investigation.The reported elongation of the product was confirmed.The tip of the sheath was not damaged.The elongation of the sheath begins at approximately 2cm from the distal end, which is probably the spot which caused the friction.Od of the sheath was measured with ring gage used for inspection of 6fr (2,88mm) - the sheath passed through the ring gauge without any complications - it is confirmed, that the product was within the specification.According to the information provided by the customer, there were no difficulties during preparation and insertion of the sheath into the patient the customer informed cmi, that the dilator was not used during removal which is inconsistent with the instructions in ifu.The end user did not follow the instructions in the ifu - the dilator was not used during the removal, which is the most likely root cause.Other potential root causes could be e.G.Patient anatomy, failure of other devices used during the procedure etc.
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