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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report number: 2029046-2021-00484 is related to the same incident.
|
This complaint is from a literature source.The following complications were reported in this publication: it was reported that 3 patients underwent catheter ablation of atrial fibrillation and suffered category 2 lesion: ulcer >5 mm diameter.Intervention included control endoscopy that was performed within 7 days.Furthermore, patients with category 2 lesions received a liquid diet until regression of edel was confirmed in a re-peat endoscopy during the initial hospital stay.All patients experiencing endoscopically detected esophageal lesions (edel) were completely asymptomatic.Model and catalog number are not available, but the suspected device is qdot micro ablation catheter.Other biosense webster devices that were also used in this study: carto 3.Non-biosense webster devices that were also used in this study: none.Publication details: title: incidence of ablation-induced esophageal injury associated with high-power short duration temperature-controlled pulmonary vein isolation using a specialized open-irrigated ablation catheter: a retrospective single-center study.Objective: to evaluate shortterm efficacy and incidence of ablation induced endoscopically detected esophageal injury in patients undergoing high power, short duration (hpsd) pulmonary vein isolation using a novel irrigated radio frequency ablation catheter and ablation generator setup.Methods: atrial fibrillation (af) patients, who underwent af ablation using an irrigated radiofrequency ablation catheter specifically designed for a hpsd ablation approach (50 w, with a target ablation index of 350 at posterior wall), received postablation esophageal endoscopy after ablation.In total 45 consecutive patients (67 ± 10 years; 58% male; 42% paroxysmal af) undergoing af ablation using a specialized ablation catheter (qdot) were included in the study.Thirty-one of 45 patients (69%) underwent a first-time pulmonary vein isolation (group 1, 67 ± 11 years; 55% male; 48% paroxysmal af).Fourteen patients (31%) underwent a redo af procedure (group 2, 66 ± 8 years; 64% male; 29% paroxysmal af).Patients undergoing first-time pulmonary vein isolation were included in the final analysis.
|