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.
|
It was reported that an attempt was made to use a impact admiral to treat a calcified plaque lesion in the mid superficial femoral artery. degree of tortuosity was little. degree of calcification was moderate.Lesion stenosis was 80%.Device was prepped per ifu with issues noted.It is reported there was a packaging issue.The sterile packaging bag was damaged and device could not be used, there was a gap at the opening of the sterile bag of the product.No obvious damage was observed in the outer box, but there was slight squeeze deformation.The device was not used in the patient.The drug-coated balloon use was cancelled and the procedure was completed.No patient injury reported.
|