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Model Number VS-404 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Itching Sensation (1943); Rash (2033); Local Reaction (2035)
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Event Date 10/18/2021 |
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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During index procedure, physician used venaseal closure device to treat 2 segments in the left great saphenous vein (gsv).Location of catheter tip prior to initial delivery of adhesive was 5cm caudal to sapheno femoral junction.There was compression of gsv.Five days post index procedure, the left aagsv was treated with non-medtronic radiofrequency ablation, micro and sclerotherapy.Seven days post index procedure, the right great saphenous vein (gsv) was treated with venaseal and sclerotherapy.Local anesthesia and hand compression were used.Ifu was followed.A guidewire was used for the insertion of the catheter.The vein closed.Approximately ten days post second venaseal treatment, patient returned for follow up with localized reaction and a rash that spread throughout the stomach and chest.Physician recommended to try benadryl.Eighteen days post index procedure or eleven days post second venaseal treatment, claritin was added.Twenty days post index procedure, a course was started of prednisone taper 50mg x 3 days decreasing by 10mg every 3 days.Benadryl and claritin were stopped and allegra was started.In addition, prescription for hydroxyzine 10mg was given at night for itching for 10 days as needed which patient has been using.Patient symptoms are reported to be improving.No further injury reported.
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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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