Product event summary: the 2ach20 mapping catheter with lot number 11151978 was returned and analyzed.Visual inspection showed the pebax tubing was ribbed and bulged at the loop at several points, part of the pebax tubing absent at the tip, and that the mapping catheter had missing electrodes.Further testing was unavailable due to the device being received damaged.In conclusion, the mapping catheter failed the returned product inspection due to ribbed and bulged pebax tubing and missing electrodes.If information is provided in the future, a supplemental report will be issued.
|