The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-03368 for product code ns7tcd8l174hs (navistar¿ ds electrophysiology catheter); this mfr # for product code f6qf002rt (webster¿ electrophysiology catheter).
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It was reported that a (b)(6) female patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a navistar¿ ds electrophysiology catheter and a webster¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.After the case was over, and they were preparing to pull the sheaths the patient¿s blood pressure dropped, and cardiac tamponade was confirmed by transthoracic echo (tee).Pericardiocentesis was performed to remove 250cc of fluid from the pericardial space.The patient was reported in stable condition after pericardial drainage.The patient stayed an extra day for observation purposes.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, physician believes the issue was caused by webster rv catheter manipulation near the end of the procedure, (after the ablation part of the procedure was over) due to non-capture and felt that the repositioning of the rv catheter resulted in the injury.He mentioned that he thinks this catheter is stiffer than some others, and that the patient¿s anatomy (thinner ventricle) might have also contributed to the adverse event.Transseptal puncture was performed with a st.Jude medical bk-1 needle.There was no evidence of steam pop.No bwi product malfunctions were reported during the case.This event will be reported under both products since the issue occurred after the ablation was concluded; therefore, it cannot be determined the issue was not related to radiofrequency (rf) delivery.
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