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 no lot number was provided by the customer.Concomitant products that used in this study: carto 3, cartomerge, lasso nav other company¿s devices that were used in this study: mullins.Manufacturer's ref.No: (b)(4).The device is not return to bwi.
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This complaint is from a literature source.It was reported that 178 patients (ai-group = 89 and cf group =89) with paroxysmal af underwent catheter ablation from january 2013 and december 2015 and were followed-up for 12 months.Among them, two major complications occurred in the cf group, while none occurred in the ai group.One patient had phrenic nerve palsy in the cf group.Based on the facts of the case and the author¿s assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title: ¿prospective use of ablation index targets improves clinical outcomes following ablation for atrial fibrillation¿ ablation index (ai), a novel ablation quality marker, incorporates contact force (cf), time and power in a weighted formula.The purpose of this study was to determine whether the prospective use of previously-published derived ai targets would result in better outcomes when compared to cf-guided ablation.Suspect device is a thermocool smarttouch, however catalog and lot number is unknown.
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