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Model Number VS-404 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Itching Sensation (1943); Rash (2033); Urticaria (2278)
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Event Date 06/22/2023 |
Event Type
Injury
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Event Description
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Physician used a venaseal kit during treatment of patients great saphenous vein (gsv).The lumen was flushed prior to use.The ifu ( instruction for use) was followed during preparation, procedure, post-procedure.A guidewire was used for the insertion of the catheter.Tumescent infiltration was not utilized.Local anesthesia was used.Compression was not used.The location of catheter tip prior to initial delivery of adhesive was 5 cm distal to junction.The catheter tip was positioned 5cm caudal to sfj.No issues noted during procedure and procedure was completed successfully.50 segments were treated and vein is reported to have closed.It is reported that one day post-op patient presented with itching of the legs and rash.Recommended to take benadryl.The next patient attended follow up ultrasound and itching had not relived with benadryl and medrol pack and hive continued to travel across torso and back/ patient prescribed vistaril and prednisone for 5 days.By 10 days later (b)(6) 2023) rash was all over stomach and chest.Issue is still present.
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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.
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Manufacturer Narrative
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Image analysis: 2 images were returned for review.Image 1: ¿image received of person with some type of rash on their body, consistent with the reported event, lot/batch number of the venaseal device or venaseal glue vial could not be confirmed based on the returned image.¿ image 2: ¿image received of text with images showing a person with some type of rash on their body, consistent with the reported event, lot/batch number of the venaseal device or venaseal glue vial could not be confirmed based on the returned image.¿ 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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