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Catalog Number SP-101 |
Device Problems
Use of Device Problem (1670); Biocompatibility (2886)
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Patient Problems
Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Reaction (2414)
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Event Date 09/22/2020 |
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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The physician used a venaseal closure system to treat the short saphenous vein.4-5 segments were treated and the vein was closed.Local anesthesia was used.Hand compression was used.The ifu was not followed during preparation, procedure, post-procedure.The blue catheter and white catheter couldn't enter to the junction of ssv well because patient's ssv was so small.The physician delivered adhesive for 2-3 segments through catheter on distal of ssv per the ifu, but then delivered adhesive directly through needle on proximal of ssv for 2 segments.A guidewire was used for the insertion of the catheter.It is reported that the patient suffered from hypersensitivity reaction after venaseal procedure.Symptoms were systemic such as itching, redness, and dyspnoea at first.The patient took medication including steroids for few days and symptoms were improving, but patient's condition is bad currently and they are currently taking medication.The physician thinks it's associated with venaseal procedure as the symptoms occurred after venaseal procedure.
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Manufacturer Narrative
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Additional information: there were no issues during the procedure that caused the physician to deliver the adhesive directly through the needle of the proximal of ssv.The patient was given another treatment besides the steroid.The patient's condition is reported to be normal.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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Patient had been also given antihistamines besides the 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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Image review the customer provided three photos of the patient reaction.The photos show redness to one of the patient's arms, back-side, and one of the patient's legs.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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Search Alerts/Recalls
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