Manufacturer's ref.No: (b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report numbers: 2029046-2021-00553 and 2029046-2021-00554 are 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 1 patient underwent catheter ablation of atrial fibrillation and suffered phrenic nerve paralysis that resolved after two months.Intervention was not reported.Model and catalog number are not available, but the suspected device is thermocool smarttouch.Other biosense webster devices that were also used in this study: lasso, pentaray, carto, visitag non-biosense webster devices that were also used in this study: none.Publication details: title: repeat catheter ablation for recurrent atrial fibrillation: electrophysiologic findings and clinical outcomes.Objective: atrial fibrillation (af) ablation is successful in 60%¿80% of optimal candidates, with many patients requiring repeat procedures.We performed a detailed examination of electrophysiologic findings and clinical outcomes associated with first repeat af ablations in the era of contact force-sensing radiofrequency (rf) catheters.Methods: we retrospectively studied patients who underwent their first repeat af ablations for symptomatic, recurrent af at our center between 2013 and 2019.All repeat ablations were performed using contact force-sensing rf catheters.Pulmonary vein (pv) reconnections at repeat ablation and freedom from atrial arrhythmia 1 year after repeat ablation were evaluated.We further assessed these findings based on af classification at the time of presentation for repeat ablation, index rf versus cryoballoon (cb) ablation, and duration (=3 versus <3 years) between index and repeat procedures.
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