BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Model Number D-1266-01-S |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Pain (1994); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Date 07/12/2017 |
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.Since no lot number was provided, no device history record (dhr) review could be performed.Full udi # information unavailable since the lot number is unknown.(b)(4).
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Event Description
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It was reported that a patient underwent an idiopathic left ventricular tachycardia ablation procedure for premature ventricular contractions (pvcs) with a navistar® rmt thermocool® electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis and surgical intervention.During ablation in the left ventricle, a pericardial effusion was confirmed via intracardiac echocardiogram (ice).Heparin was reversed per protocol.Pericardiocentesis was performed and yielded an unspecified amount of fluid.Patient was reported to be in stable condition.At the end of the procedure, the patient reported pain and became hypotensive.Patient was transferred to the operating room for surgical repair of a left ventricular apex perforation.Patient was reported to be awake and in stable condition.It was noted that the perforation was in the left ventricular apex and ablation was performed in the posteroseptal area near the valve.Activated clotting time at the time of injury was approximately 350 seconds.It was noted that the physician believes the navistar rmt thermocool catheter to be responsible for the injury.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.
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