This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on (b)(6) 2018.Upon further investigation of the reported event, the following information is new and/or changed.(b)(4).The actual device was not returned for evaluation nor were any pictures provided.A review of history records could not be performed as lot number was not provided.Additionally, a retention sample could not be obtained.Upon evaluation, it could not confirmed that the incorrect product was shipped.The complaint could not be confirmed, and definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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