According to the reporter, during an harvest of the great saphenous vein as coronary artery bypass grafting (cabg), open procedure, the device was misfiring and unable to be used.The surgeon was able to squeeze the handle.Individual self-loading liga applicators used in place.
|
D10 concomitant products: 133650, 133650 premium surgiclip iii 9.0 (lot#p3h1106); 133650, 133650 premium surgiclip iii 9.0 (lot#p3h1106); 133650, 133650 premium surgiclip iii 9.0 (lot#p3h1106); 133650, 133650 premium surgiclip iii 9.0 (lot#p3h1106); 133650, 133650 premium surgiclip iii 9.0 (lot#p3h1106).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|