Manufacturer's ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.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 the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's report number: 2029046-2020-01232 is related to the same incident.
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This complaint is from a literature source.The following complications were reported in this publication: it was reported that 2 patients underwent catheter ablation of atrial fibrillation and suffered pulmonary vein stenosis (severe) >70% diameter reduction of pulmonary vein.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is lasso.Other biosense webster devices that were also used in this study: none.Non-biosense webster devices that were also used in this study: chilli.Publication details title: use of intracardiac echocardiography for prediction of chronic pulmonary vein stenosis after ablation of atrial fibrillation objective: measurement of pv flows with ice before and after ablation has been proposed as a method for predicting which patients will develop chronic pv stenosis.However, this hypothesis has never been tested.Methods: consecutive patients who were referred to our laboratory for af ablation procedures were included in the study.Antiarrhythmic drugs and warfarin were discontinued five half-lives and 3 days before the ablation, respectively.Amiodarone was withdrawn 4 to 5 months before the procedure.For patients who presented in af on the day of the study, a transesophageal echocardiogram was done immediately before the ablation to exclude the presence of thrombus in the left atrium.
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