Product event summary: the mapping catheter 990063-020 with lot 216868941 was returned and analyzed.Visual inspection of the mapping catheter showed the loop was separated from the pebax.The loop has several kinks, one knot and electrode were displaced.In conclusion, the reported mapping catheter kink was confirmed through testing.The mapping catheter 990063-020 with lot failed the returned product inspection due to the loop separation from the pebax, several kinks, one knot, and electrode displacement.If information is provided in the future, a supplemental report will be issued.
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