The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
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Related manufacturer reference number: 3005334138-2020-00191, 3008452825-2020-00240.The following event was found during a search of the maude database performed on 29 april 2020, report number: 2029046-2019-04029: it was reported that a male patient, underwent atrial fibrillation (afib) ablation procedure with thermocool smart touch sf bi-directional navigation catheter and suffered a cardiac tamponade and cardiac arrest resulting in surgical intervention and death.Patient came for a premature ventricular contraction (pvc) ablation with pre-existing bi-ventricular pacemaker.Ejection fraction was unknown.Transseptal was performed to access lv through the mitral valve.Case was completed and there was no mention of reduced blood pressure during the case.There were no concerns regarding product or product issues noted during the case.With removal of catheters and awakening from anesthesia, it was noted that the patient had a reduced blood pressure.Echocardiogram then demonstrated a pericardial effusion.Pericardiocentesis was performed and 500 ml of blood was removed.At this time, despite pacing, myocardium was not contracting.Resuscitative efforts were performed including chest compressions and use of epinephrine.Patient was placed onto ecmo and after approximately 90 minutes, patient was transferred to the operating room.A tear was noted in the aorta.No product was used in the aorta and the tear most likely occurred with transseptal procedure.After repair, there was still limited cardiac function and the patient expired an hour or so after surgery.Physicians opinion of cause is because of the transseptal during procedure.
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