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Model Number NAVISTAR |
Device Problem
Insufficient Information (3190)
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Patient Problems
Transient Ischemic Attack (2109); Complaint, Ill-Defined (2331)
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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.One patient (b)(6) year old 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.Article title: "low incidence of permanent complications during catheter ablation for atrial fibrillation using open-irrigated catheters: a (b)(4)" 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: one patient (b)(6) year old 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.
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Manufacturer Narrative
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Manufacturer ref # (b)(4).One patient (b)(6) year old 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.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.One patient had phrenic nerve paralysis during right pv isolation without permanent damage.One patient (b)(6) year old 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.One patient (b)(6) year old 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 ((b)(6)) suffered vascular access complications.13 patients ((b)(6)) developed cardiac tamponade, successfully drained in all the cases.4 patients had transient ischemic attack.5 patients ((b)(6)) presented pericardial effusion not requiring specific intervention.3 patients ((b)(6)) had pericarditis.3 patients ((b)(6)) had haemothorax requiring drainage in two cases.One 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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