Product event summary: the mapping catheter 990063-020 with lot number 218320597 was returned and analyzed.Visual inspection showed the pebax tubing was stuck in the introducer and the loop was kinked.The introducer was received tight in the middle of the pebax tubing and which caused damage.The inability to insert the mapping catheter into lab test catheter was observed, due to the loop kinks.In conclusion, the mapping catheter failed the returned product inspection due to a loop kink.If information is provided in the future, a supplemental report will be issued.
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