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Catalog Number VS-404 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Rash (2033)
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Event Date 11/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician used the venaseal closure system to treat 45cm, 20cm, 20cm segments respectively of the great saphenous vein (gsv), short saphenous vein (ssv) <(>&<)> anterior accessory great saphenous vein (aagsv) on three separate dates.General anaesthesia and hand compression were used.The lumen was flushed prior to use and a guidewire was used for insertion of the catheter.Ifu was followed.The vein is reported to have closed.Patient described full body hives 18 days post implant.Patient went to the emergency room three times for iv medication because the hives were persistent and did not get better with over-the-counter medication.Patient also had two rounds of steroid pack.Patient was told to take benadryl, ioratadine <(>&<)> ceterizine.No further injury reported.
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Manufacturer Narrative
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There were no challenges or deviations with regard catheter location during delivery.The catheter tip was 5cm from the junction, gsv was compressed with hand.Issue has resolved after three rounds of steroids.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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