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Catalog Number VS-404 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Erythema (1840); Discomfort (2330); Swelling/ Edema (4577)
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Event Date 03/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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An image was provided for evaluation.The image is of the patients leg with an area of the posterior thigh outlined.There appears to be erythema of the skin.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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Venaseal was used to treat the great saphenous vein (gsv) on the (b)(6) 2022.The ifu was followed.Hand compression was used.There were no challenges or deviations related to the location of the catheter tip prior to initial delivery of adhesive and the catheter tip was positioned 5cm caudal to sfj.Compression was applied at the gvs for the ¿plug¿.The gsv was compressible after the treatment.The procedure was successful.During a follow-up visit the patient had slight swelling, swelling, tenderness and redness.The reaction appeared on the upper right leg 7 weeks post op.Treatment (augmentin for 10d ) was prescribed, unable to use nsaids for renal issues.The issues are still present and have not been resolved.
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Search Alerts/Recalls
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