During a literature search, atricure determined a patient experienced an adverse event prior to 2016 which may have been caused or contributed to by the csk-6130 cannula.The case study was published in annals thoracic surgery 2017, in which literature reported a patient presented with acute onset epigastric abdominal pain and nausea.The patient had a convergent procedure via transdiaphragmatic approach 16 months prior.Ct demonstrated diaphragmatic hernia with loops of thickened small bowel within the pericardium and a small pericardial effusion.The patient underwent laparotomy and repair of the diaphragmatic hernia.The patient tolerated the procedure well and was discharged on pod2 without further adverse events.There was no reported device malfunction and the adverse event was the result of a procedural complication.Sub-xiphoid access is the preferred approach for the convergent procedure.Source: kaufman aj, kahn et, villena-vargas j, steele jg, flores rm.Laparoscopic repair of an intrapericardial diaphragmatic hernia after convergent maze procedure.Ann thorac surg.2017;103(6):e541-e543.".
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