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The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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It was reported that an unknown female patient underwent an atrial fibrillation (afib) ablation procedure with a unk_smart touch bidirectional sf.The patient suffered cardiac tamponade requiring surgical intervention and prolonged hospitalization.It was reported that during an afib procedure that was performed on (b)(6) 2022, the patient was observed to have a pre-procedure small pericardial effusion.They proceeded with the procedure and then midway through the procedure they thought that the effusion may be getting larger.A trans-esophageal echocardiogram (echo) was performed and the concluded that the effusion was actually not getting larger.The procedure was discontinued and the patient was transferred to the critical care unit (ccu) for observation.The patient remained stable throughout.The physician¿s opinion on the cause of this adverse event is that it was the procedure and patient condition.Medical intervention provided was pericardial window.The patient outcome of the adverse event is fully recovered.The patient did require extended hospitalization because of the adverse event, but the reason is unknown to the reporter.Relevant tests/laboratory data: none related.Other relevant history: noted pericardial effusion early in procedure.Generator information: stockert smartablate sn: (b)(4).A transseptal puncture was performed with a baylis nrg needle.Prior to noting the pulmonary embolus (pe) or computerized tomography (ct), ablation was not performed.There was no evidence of steam pop.It is unknown when the event specifically occurred.An irrigated catheter was used in the event, the flow setting was high flow 8.15ml, low flow 2 ml, pre and post rf time 2 s.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used were: graph, dashboard, vector, and visitag.The visitag module was used, the parameters for stability used were: 2.5 mm, 3 sec, 25% force, 3g minimum.No additional filter was used with the visitag.Color option used prospectively was fti.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
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