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: 2029046-2020-01389 and 2029046-2020-01390.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 3 patients underwent catheter ablation of atrial tachycardias and suffered cerebral embolic events (thrombus).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.Other biosense webster devices that were also used in this study: none non-biosense webster devices that were also used in this study: st.Jude medical inquiry catheter, dynamic deca, orion min-basket catheter, rhythmia system, intellanav, sl0 long sheath, zurpaz sheath, publication details title: outcome after tailored catheter ablation of atrial tachycardia using ultra-high-density mapping.Objective: tailored catheter ablation of atrial tachycardias (ats) is increasinglyrecommended as a potentially easy treatment strategy in the era of high densitymapping (hdm).As followup data are sparse, we here report outcomes after hdm guided ablation of ats in patients with prior catheter ablation or cardiac surgery.Methods: in 250 consecutive patients (age 66.5 ± 0.7 years, 58% male) withats (98% prior catheter ablation, 13% prior cardiac surgery) an hdm¿guided catheterablation was performed with the support of a 64 electrode mini basket catheter.A totalof 354 ats (1.4 ± 0.1 ats per patient; mean cycle length 304 ± 4.3 ms; 64% macroreentry,27%localized reentry, and 9%focal)with acute termination of 95% were targeted in the index procedure.
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