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This complaint is from a literature source.The following literature cite has been reviewed: yui y, sekiguchi y, nogami a, yamasaki h, machino t, kuroki k, igarashi m, aonuma k, ieda m.Midterm outcomes of catheter ablation for atrial fibrillation in patients with cardiac tamponade.J arrhythm.2018 oct 24;35(1):109-120.Doi: 10.1002/joa3.12127.Pmid: 30805051; pmcid: pmc6373639.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).
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This complaint is from a literature source.The following literature cite has been reviewed: yui y, sekiguchi y, nogami a, yamasaki h, machino t, kuroki k, igarashi m, aonuma k, ieda m.Midterm outcomes of catheter ablation for atrial fibrillation in patients with cardiac tamponade.J arrhythm.2018 oct 24;35(1):109-120.Doi: 10.1002/joa3.12127.Pmid: 30805051; pmcid: pmc6373639.Objective/methods/study data: background: cardiac tamponade is a serious complication of catheter ablation for atrial fibrillation (af).However, the outcomes of catheter ablation in patients of cardiac tamponade are unknown.Methods: we performed catheter ablation in 2467 sessions of af or a recurrence of af between january 2007 and january 2016.Of these, 29 events in 27 patients (1.18%: 22 men; 64.5 ± 10.4 years; 17 with paroxysmal af) of cardiac tamponade during or after the procedure were recorded.The clinical characteristics and outcomes of these 29 events were studied in detail.Results: of the 19 events where the ablation procedure was completed, seven events developed acute recurrence of af (36.8%).Of the 10 events with an incomplete procedure, 10 exhibited af recurrence (100.0%).Direct oral anticoagulants were used in seven events, and clinical outcomes were not significantly different compared to the remaining 21 events that were prescribed warfarin.Pericarditis occurred in 10 events (34.5%) after the procedure, and the incidence rate was lower in patients receiving prophylactic nonsteroidal anti-inflammatory drugs or steroids (2/15, 13.3% vs 8/14, 57.1%; p = 0.013).Repeated sessions were performed in 12 events (two with a complete initial procedure, 10 with an incomplete initial procedure).Freedom from atrial arrhythmias was observed in 27 events (93.1%, 9 with antiarrhythmic drugs) over midterm follow-up (3.1 ± 2.6 years).Conclusion: although cardiac tamponade caused by catheter ablation led to a high rate of acute af recurrence and pericarditis, the midterm recurrence rates of af are unaffected if the procedure can be completed.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: unknown thermocool concomitant biosense webster devices that were used in this study: smarttouch, carto 3 system concomitant non-biosense webster devices that were also used in this study: ensite navix (st jude medical), flexcath, (medtronic inc), achieve (medtronic inc.), 28 mm advance balloon (medtronic inc), cardiolab system (prucka engineering) adverse event(s) and provided interventions possibly associated with unidentified thermocool irrigated deflectable catheter (table 2): patient #2: 73 year old male experienced (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention) and hospitalization (prolonged hospitalization) (adverse event) patient #7: 75 year old female experienced (cardiac tamponade) with medication and hospitalization (prolonged hospitalization) (adverse event) patient #13: 70 year old male with history of asd post operation that experienced (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention) and hospitalization (prolonged hospitalization) (adverse event) patient #18: 65 year old experienced (pericarditis) and (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention), and hospitalization (prolonged hospitalization) (adverse event) patient #19: 65 year old male experienced (pericarditis) and (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention) and hospitalization (prolonged hospitalization) (adverse event) patient #20: 61 year old male experienced (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention) and hospitalization (prolonged hospitalization) (adverse event) patient #21: 60 year old with a history of hocm, experienced (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention) and hospitalization (prolonged hospitalization) (adverse event) patient #22: 64 old year male experienced (cardiac tamponade) with medication and hospitalization (prolonged hospitalization) (adverse event) patient #24: 80 year old female experienced (pericarditis) and (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention) and hospitalization (prolonged hospitalization) (adverse event) patient #26: 66 year old experienced (pericarditis) and (cardiac tamponade) that required pericardiocentesis and drain placement (surgical intervention) and hospitalization (prolonged hospitalization) (adverse event) for medication: seven events immediately recovered from hypotensive episodes after transvenous injection of noradrenalin and extracellular fluid; therefore, observational therapy was selected.
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