Event summary: the patient data files showed on the date of the event that twelve applications were performed without issue.The flexcath advance sheath (4fc12/52009) was not returned for investigation.This complaint is about several clinical issues encountered (st elevation, air ingress) during the procedure.No product malfunction reported.The reported issue does not indicate manufacturing related defect.In conclusion, this event is about several clinical issues encountered (st elevation, air ingress) during the procedure.The sheath was not returned for investigation.
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