(b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's reference # (b)(4).
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It was reported that a patient underwent pulmonary vein isolation (pvi) procedure and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the procedure a cardiac perforation occurred.The patient had become hypotensive and an intracardiac echocardiography (ice) revealed a perforation of the pulmonary artery.A pericardiocentesis was performed to remove unspecified amount of fluid from the pericardial space.The patient was transferred to the operating room for surgical repair and stabilization.There¿s no information regarding extended hospitalization, patient¿s outcome or physician causality opinion.It was confirmed that no biosense webster, inc.Representative was present for the case.There¿s no information that a therapeutic biosense webster, inc.Catheter was used during the procedure.No biosense webster, inc.Product malfunctions were reported.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.
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