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.Manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2020-01171 and 2029046-2020-01182 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 who underwent pulmonary vein isolation cardiac ablation suffered phrenic nerve palsy (diaphragmatic paralysis).Intervention was not reported.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 thermocool smarttouch (st) other biosense webster devices that were also used in this study: lasso ,carto visitag.Non-biosense webster devices that were also used in this study: na.Publication details: title: reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the air registry.Objective: ablation index (ai) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies.This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (pv) isolation guided by the ai.Methods: a total of 490 consecutive patients with paroxysmal (80.4%) and persistent af underwent first time pv isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (st) or contact force surround flow (stsf) catheter) and the ai setting (330-450 or 380-500 at anterior wall or posterior wall, respectively).
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