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.Biosense webster manufacturer's report numbers: 2029046-2020-01323, 2029046-2020-01324, 2029046-2020-01325, 2029046-2020-01334, 2029046-2020-01336, 2029046-2020-01337.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 2 patients underwent catheter ablation of atrial fibrillation and suffered pseudoaneurysm.Intervention was required longer hospital stay.(thermocool® ablation catheter ) model and catalog number are not available, but the suspected devices are: thermocool® ablation catheter.Other biosense webster devices that were also used in this study: biosense webster soundstar catheter, carto lasso, carto pentaray , carto 3 non-biosense webster devices that were also used in this study: boston scientific intellamap orion¿, boston scientific intella nav¿ open-irrigated ablation catheter, boston scientific intella tip mifi¿ open irrigated ablation catheter, boston scientific rhytmia® hdm publication details title: advantages of the integration of ice and 3d electroanatomical mapping and ultrasound-guided femoral venipuncture in catheter ablation of atrial fibrillation objective: to evaluate how the integration of intracardiac echocardiography (ice) and ultrasound-guided femoral venipuncture (usgvc) may affect the safety of catheter ablation (ca) of atrial fibrillation (af).Methods: from a single center 374 patients with af underwent 3d electroanatomic mapping¿guided ca with or without the integration of ice and usgvc.The primary endpoints were periprocedural complications, fluoroscopy time, and procedure time between the two groups.
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