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Catalog Number VS-403 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 04/06/2024 |
Event Type
Injury
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Event Description
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A venaseal closure system was used for treatment of the great saphenous vein on the (b)(6) 2024. there were no particularly notable procedures or patient backgrounds.On the (b)(6) 2024, the treated site had become swollen and the patient had a fever (approximately 37.7).On the (b)(6) 2024 the patient was prescribed antibiotics at another facility.Infection was suspected based on blood test results.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Additional information: treatment for gsv in one leg only.There were no challenges or deviations related to the location of catheter tip prior to initial delivery of adhesive and the catheter tip was 5cm caudal to sfj.There was compression of the gsv, there is no difference from normal usage and the ifu was followed.Sterile techniques were followed, at the time of treatment, gowns were also worn and aseptic operation.On april 9, the physician contacted the sales rep to say that the patient felt better after antibiotic treatment.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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