ST. JUDE MEDICAL, INC (AF-MINNETONKA) REFLEXION SPIRAL VAR. RADIUS CATH, 7F, SM CRL, SWP
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Model Number 402804 |
Device Problem
Extrusion (2934)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Diaphoresis (2452)
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Event Date 03/21/2014 |
Event Type
Injury
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Event Description
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Related mfr ref: 3008452825-2014-00012, 305188751-2014-00063; 00064; 00065; 00066; and 00067.Following an atrial fibrillation procedure, a pericardial effusion occurred.Two transseptal punctures were performed with a brk transseptal needle and a swartz braided transseptal introducer and an agilis nxt introducer were advanced into the left atrium.An inquiry decapolar ep catheter was placed in the coronary sinus.A reflexion spiral ep catheter, and inquiry afocus ii ep catheter, and a tacticath ablation catheter were all used in the left atrium for mapping and ablation.Left and right wide area circumferential ablation (waca) were successfully performed around the pulmonary veins.The pt developed transient hypotension during the right waca but blood pressure returned to normal immediately.The procedure was completed and the pt converted to sinus rhythm.After the procedure, the pt became hypotensive and diaphoretic and an echocardiogram revealed a pericardial effusion a pericardiocentesis was performed, which stabilized the pt.The pt was discharged home a few days later and remained in sinus rhythm.There were no performances issues with any sjm device.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the info received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is an inherent risk during the use of this device.
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