(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.Cerenovus manufacturer's report numbers: 2029046-2020-00087 and 2029046-2020-00089 are related to the same incident.
|
This complaint is from a literature source.As reported in the literature publication entitled, ¿impact of preprocedural serum eicosapentaenoic acid to arachidonic acid ratio on post-ablation recurrence of atrial fibrillation¿ (pmid: 31735788).1 patient with atrial fibrillation who underwent first-time radiofrequency catheter ablation which was performed using an open-irrigated ablation catheter navistar thermocool experienced right coronary air embolization that required intervention with aspiration system.192 patients were enrolled.Patients were divided into two groups using the median serum epa/aa ratio.Patient characteristics, electrophysiological findings, and the incidence of af recurrence post ca were compared between the low and high groups.The principle strategy was extensive encircling pulmonary vein isolation (pvi) which was performed using an open-irrigated ablation catheter (navistar thermocool, biosense-webster, (b)(4), usa).We used the double-lasso technique under the guidance of a 3d mapping system (carto xp or carto3) bwi devices were used in this study.No devices specific information (including catalog and lot number) were provided in the article.Concomitant devices were: carto3 or carto xp mapping system.
|