The deltaplush cerecyte microcoil 2 mm x 6 cm (cpl10020630/ g10518) got stuck in an echelon 10 microcatheter (details unknown).New same coil (details unknown) was used after this; but it also got stuck.Several deltaplush were used this time and only this lot had problems.The deltaplush cerecyte microcoil 2 mm x 6 cm (cpl10020630/ g10518) was received severely damaged.The evidence as received suggests that distal interference inside the microcatheter may have contributed to the complaint event.The inference was most likely temporarily in nature.The exact source of this interference cannot be determined as both the microcoil system and the microcatheter were cleaned before being returned.Concerning the echelon 10 microcatheter used in the procedure, the unit passed both inspection and functionality testing.Based on the information and the analysis, the event ¿coil damaged¿ was confirmed but the event ¿dcs impeded-in microcatheter¿ could not be confirmed.No corrective actions will be taken at this time.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.This is 1 of 2 reports associated with (b)(4).Concomitant medical products and therapy dates: echelon 10 microcatheter (details unknown); new coil (details unknown).
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