ST. JUDE MEDICAL, INC. (AF-MINNETONKA) AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, SMALL CURL, 8.5F; INTRODUCER, CATHETER
|
Back to Search Results |
|
Model Number 408309 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problems
Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
|
Event Date 09/30/2014 |
Event Type
Injury
|
Event Description
|
Related manufacturer reference 3005188751-2014-00127, 3005188751-2014-00128, 3005188751-2014-00130, 2030404-2014-00097.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Two transseptal punctures were completed using a brk needle and a swartz braided transseptal introducer.The introducer was exchanged with an agilis nxt introducer, through which a safire blu duo ablation catheter was advanced into the left atrium.A reflexion spiral ep catheter was also advanced into the left atrium.The patient became hypotensive and a pericardial effusion was noted via a non-sjm ice catheter.The procedure was stopped and a pericardiocentesis was performed, which stabilized the patient.Once the patient was stable, a cavotricuspid isthmus line ablation was performed.The patient remained stable and was transferred to the icu for observation.There were no performance issues with any sjm device.
|
|
Manufacturer Narrative
|
Additional information: the results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.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.
|
|
Search Alerts/Recalls
|
|
|