Catalog Number UNK_SMART TOUCH BIDIRECTIONAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pseudoaneurysm (2605)
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Event Date 07/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Biosense webster manufacturer's report numbers: 2029046-2020-00715, 2029046-2020-00716, 2029046-2020-00717, 2029046-2020-00718, and 2029046-2020-00719 are related to the same incident.
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Event Description
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This complaint is from a literature source.As reported in the literature publication entitled ¿isolating the entire pulmonary venous component versus isolating the pulmonary veins for persistent atrial fibrillation: a propensity-matched analysis.¿ 2 patients with persistent atrial fibrillation who underwent pulmonary vein isolation (from pv-comp -group) experienced femoral pseudoaneurysm.Objective: to present an alternative strategy with pvcomp isolation.The entire pulmonary venous component (pv-comp), consisting of the pulmonary veins, their antra, and the area between the antra, provides triggers and substrate for af.Pvcomp isolation is an alternative strategy for persistent af ablation.Methods: in the period between january 2014 and july 2018, among 328 patients with persistent af who underwent a first radiofrequency ablation procedure, 200 patients (pvi, n = 100; pv-comp isolation, n = 100) were selected by propensity score matching.Both groups were followed up for 1 year.
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Search Alerts/Recalls
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