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.Manufacturer's report number: 2029046-2021-01231 is related to the same incident.
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This complaint is from a literature source.The following complications were reported in this publication: two groups were involved in this study.A total of 100 patients underwent an index superior vena cana isolation (svci) using high power, short duration (hpsd) ablation or conventional lower power and longer duration (lpld group) ablation, using the thermocool smarttouch sf.It was reported that 3 patients underwent superior vena cava isolation (svci) ablation in the lpld group suffered right phrenic nerve injury.Intervention was not reported.The degree of the right diaphragmatic elevation was mild, which was half of the height of one vertebra, 12 and no symptoms associated with pni were observed in all three patients.No other complications related to the svc ablation, including sinus node injury or steam pops, were observed in any patients.Model and catalog number are not available, but the suspected device is thermocool smarttouch sf.Other biosense webster devices that were also used in this study: lasso , visitag non-biosense webster devices that were also used in this study: none.Publication details: title: superior vena cava isolation with 50 w high power, shortduration ablation strategy.Objective: the optimal ablation strategy is unkn own regard ing a super ior vena cavaisolation (svci).This study a imed to examine the feasibility and safety and to analyze the lesion characteristics of the svci using high power, short duration (hpsd) ablation.Methods: a total of 100 patients underwent an index svci using hpsd(n = 50, hpsd group) or conventional lower power and longer duration (n = 50,lpld group) ablation, using the thermocool smarttouch sf.
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