Product event summary: the data files for the date of the reported event were returned and analyzed.The data files confirmed that three different balloon catheters had been used during the procedure.It was noted that the data files also showed a system notice unrelated to the reported issue.The sheath, 4fc12 with lot 81710, was not returned for investigation.A clinical issue (st elevation) was encountered during the procedure and resolved immediately.In conclusion, the reported air ingress was unable to be confirmed as the product was not returned; the root cause remains inconclusive.A clinical issue (st elevation) was encountered during the procedure.
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