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Model Number NAVISTAR |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Nerve Damage (1979); Transient Ischemic Attack (2109); Peroneal Nerve Palsy (2362); Thromboembolism (2654)
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Event Date 01/01/2011 |
Event Type
Injury
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Event Description
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This complaint is from literature source.-1 patient (b)(6) y.O female with a prior history of paroxysmal atrial fibrillation, hypertension, diabetes and chads2 score of 2.During right pv isolation procedure, the patient developed permanent symptomatic phrenic nerve palsy.The physician opinion regarding this event is that impedance monitoring, and strict monitoring of phrenic nerve function by means of regular pacing of the nerve, from the superior vena cava and the left atrium, before ablation, are crucial to avoid this complication, and should become mandatory during ablation especially of the right pvs.Article title: "low incidence of permanent complications during catheter ablation for atrial fibrillation using open-irrigated catheters: a multicenter registry" the aim of the present study was to assess the incidence of complications with permanent sequelae of ca for af using open-irrigated catheters in a contemporary, unselected population of consecutive patients.2167 patient were enrolled into this study from january 1 and december 31, 2011.From the article other complications were reported: -1 patient (b)(6) y.O female with a prior history of persistent atrial fibrillation, hypertension and chads2 score of 1.After the cardiac ablation procedure, the patient developed ischemic stroke.The physician opinion regarding this event is that some embolic events may have been caused by thermally induced blood clots and this phenomenon is totally unresponsive to anticoagulation.There is no claim of malfunction.-1 patient (b)(6) y.O female with a prior history of persistent atrial fibrillation, hypertension, diabetes and chads2 score of 6.After the cardiac ablation procedure the patient developed ischemic stroke.
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Manufacturer Narrative
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(b)(4).Contd desc of event: the patient had previous cerebrovascular accident in the past.The physician opinion regarding this event is that some embolic events may have been caused by thermally induced blood clots and this phenomenon is totally unresponsive to anticoagulation.There is no claim of malfunction.1 patient had phrenic nerve paralysis during right pv isolation without permanent damage.1 patient (b)(6) y.O female with a prior history of paroxysmal atrial fibrillation, hypertension, and chads2 score of 1.During right pv isolation the patient developed permanent symptomatic phrenic nerve palsy.The physician opinion regarding this event is that impedance monitoring, and strict monitoring of phrenic nerve function by means of regular pacing of the nerve, from the superior vena cava and the left atrium, before ablation, are crucial to avoid this complication, and should become mandatory during ablation especially of the right pvs.1 patient (b)(6) y.O male with a prior history of atrial fibrillation and chads2 score of 1.After the cardiac ablation procedure the patient developed hemorrhagic stroke.46 patients (2.1%) suffered vascular access complications 13 patients (0.6%) developed cardiac tamponade, successfully drained in all the cases 4 patients had transient ischemic attack 5 patients (0.2%) presented pericardial effusion not requiring specific intervention 3 patients (0.1%) had pericarditis 3 patients (0.1%) had haemothorax requiring drainage in two cases 1 patient had transient st segment elevation no procedure-related death was reported.The bwi devices used are: navistar thermocool, or thermocool sf, cartotm system.However, catalog numbers are not available.Also non bwi products were used during this study: coolpath (st jude medical inc.Endocardial solutions); cooflex (st jude medical inc.Endocardial solutions); ensitenavxtm (st jude medical inc.Endocardial solutions).
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Search Alerts/Recalls
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