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 numbers: 2029046-2020-01398, 2029046-2020-01401, 2029046-2020-01402, 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 (b)(6) patient underwent catheter ablation of atrial fibrillation and suffered thromboembolic complications.Intervention was not reported.(smart touch sf).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 smart touch sf other biosense webster devices that were also used in this study: carto3, thermocool st.Non-biosense webster devices that were also used in this study: medtronic arctic front advance.Publication details: title: impact of female sex on clinical presentation and ablation outcomes in the circa-dose study.Objective: this study sought to evaluate sex-specific differences in atrial fibrillation (af) presentation and catheter ablation outcomes in the prospective, multicenter, randomized circa-dose (cryoballoon vs.Irrigated radiofrequency catheter ablation: double short vs.Standard exposure duration) study.Methods: this study examined sex-specific differences in af presentation, symptom severity and health-related quality of life, symptomatic and asymptomatic arrhythmia recurrence, af burden, and health care utilization.
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