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Device Problem
Biocompatibility (2886)
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Patient Problems
Local Reaction (2035); Urticaria (2278)
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Event Date 09/10/2023 |
Event Type
Injury
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Event Description
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A venaseal closure system was used to treat a patients great saphenous vein (gsv) on (b)(6) 2023.Prior to the procedure zyrtec was taken orally and continued for four days post procedure.The product preparation was carried out as per the ifu.No unusual methods or deviations regarding the position of the catheter tip before adhesive delivery, priming was completed as per ifu to create air at the tip.The catheter tip was 5cm caudal to sfj.Compression was also done as per ifu.No elastic stockings have been worn since surgery.1 day post procedure ((b)(6) 20230 urticaria appeared on the whole body.The following day ((b)(6) 2023) the patient started taking celestamine, due to repeated symptom relief and recurrence with oral steroid.Prednisone (20mg) was started ((b)(6) 2023) and continued.Solcoteph (250 mg) infusion was administered ((b)(6) 2023).It is stated the issue is due to foreign material reaction or allergy after the venaseal procedure.The problem is still ongoing.
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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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Manufacturer Narrative
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Image analysis 3 film images were returned for review.Image 1: ¿image received of patient¿s leg with slight redness apparent on the leg, consistent with the reported event.Lot number/adhesive batch number of the device could not be confirmed based on the returned image.¿ image 2: ¿image received of patient¿s leg with slight redness apparent on the leg, consistent with the reported event.Lot number/adhesive batch number of the device could not be confirmed based on the returned image.Image 3: image received of patient¿s body with slight redness apparent on the chest/torso, consistent with the reported event.Lot number/adhesive batch number of the device 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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