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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 reference number: (b)(4).
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This complaint is from a literature source.The following literature cite has been reviewed: liang jj, ghannam m, bogun f.Late multimodality imaging after steam pops during radiofrequency catheter ablation for ventricular arrhythmias.Jacc clin electrophysiol.2020 oct;6(10):1332-1334.Doi: 10.1016/j.Jacep.2020.05.038.Pmid: 33092763.Objective/methods/study data: steam pops are frequent events that occur during radiofrequency catheter ablation (ca) of ventricular arrhythmias (vas).They occur due steam pops are frequent events that occur during radiofrequency catheter ablation (ca) of ventricular arrhythmias (vas).They occur due to overheating of tissue and may result in devastating effects.We describe late imaging findings in 4 patients after ca of vas in whom intraprocedural steampops occurred.Steam pops that occur during ca can result in cardiac perforation, ventricular septal defects, or systemic thromboembolism.Although the observed imaging lesions could also have been the result of extensive ablation, in a series of 59 consecutive patientsnwho underwent repeat procedures with previous imaging, we only saw these imaging findings if a steam pop occurred during the index procedure.No patients in our series had any serious complications after the steam pop.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool sf, biosense webster.Other biosense webster devices that were also used in this study: n/a, non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions:patient #1 was a (b)(6) man with frequent premature ventricular contractions (pvcs) in whom a steam pop occurred during ablation at the basal inferoseptal left ventricle (lv).Subsequent cardiac magnetic resonance imaging (cmri) 5 months post-ablation demonstrated a large crater like deformation along the basal inferoseptum.Patient #2was a (b)(6) manwith frequent pvcs in whom a steam pop occurred during ablation at the septal right ventricular outflow tract (rvot).Cmri 2 months later showed a crater-like indentation along the basal septal rv with no ventricular septal defect.Patient #3 was a (b)(6) man with remote inferior myocardial infarction who underwent ca for sustained ventricular tachycardia (vt) and implant able cardioverter-defibrillator (icd) shocks.During ca along the basal inferior lv, a steam pop occurred.Coronary computed tomography angiography (cta) 4 months later showed aneurysmal outpouching of the basal inferior wall (figure 1c) that was not seen on pre-procedural cta.Patient #4 was a (b)(6) man with ischemic cardiomyopathy with recurrent vt and icd shocks who underwent ca.A steam pop occurred during ablation at the lv apex during the procedure.Cta 4 months later showed an aneurysmal outpouching at the lv apex (figure 1d) that was not seen on preprocedural cta.No interventions were mentioned in this article.
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