BIOSENSE WEBSTER INC WEBSTER ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY
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Catalog Number WEBQUADFIXED |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Tamponade (2226); No Code Available (3191)
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Event Date 04/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Concomitant product: biosense webster, inc.Product - thermocool® sf nav bi-directional catheter, catalog #: bni35fjct, lot #: unknown.Non-biosense webster, inc.Product - st.Jude medical brk transseptal needle, catalog #: unknown, lot #: unknown.Manufacturer's reference #: (b)(4).
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Event Description
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It was reported that a female patient underwent an atrioventricular reentry tachycardia with wolff parkinson white syndrome (avrt/wpw) ablation procedure with a webster¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the procedure, the patient¿s blood pressure dropped, and cardiac tamponade was confirmed by intracardiac echo (ice).Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium; however, patient¿s condition worsened after pericardial drainage and was transferred to the operating room (or) for cardiothoracic surgery.The event was assessed as life threatening due to the surgical intervention performed.Extended hospitalization was required as a result of the adverse event.Physician assumed the ablation catheter had caused an effusion but once the patient went to ct surgery it was revealed that assumption was incorrect.The root cause was actually the quadripolar catheter that was placed in the right ventricle (rv).Transseptal puncture was performed with a st.Jude medical brk transseptal needle.No error messages were observed on any biosense webster, inc.Equipment during the case.The patient received anticoagulant (unspecified), the activated clotting time (act) was maintained at >350s while in the left atrium.The patient had atrioventricular reentry tachycardia (avnrt), ablation was not performed in the right atrium (ra) after ablating the accessory pathway and anticoagulation was not given once the catheter was removed from the left atrium.The physician believed the adverse event was caused by a webster¿ electrophysiology catheter.
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