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Catalog Number VS-403 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Fever (1858); Unspecified Infection (1930)
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Event Date 06/12/2023 |
Event Type
Injury
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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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Event Description
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On (b)(6) 2023 physician used a venaseal closure system to treat the patient¿s right small saphenous vein (ssv) (c6 ulcer case) and left great saphenous vein (gsv).Tumescent infiltration was not utilized.General anesthesia was used.No compression was used.Little vessel tortuosity was reported.The ifu (instruction for use) was followed during catheter preparation, procedure, post-procedure.Sterile techniques were followed.The total length of the vein treated was 10cm with a total volume of 0.5cc glue used.A guidewire was used during catheter insertion and placement.The catheter tip was 5cm caudal to sfj.5 segments were treated and vein is reported to have closed.On (b)(6) 2023 patient visited hospital emergency room with a fever.On (b)(6) 2023 the patients right lower leg ulcer area became infected, resulting in effusion and foul odour.The infection was only present in the right leg.For about 20 days, the ulcer infection subsided after using antibiotics (bacta tablet).On (b)(6) 2023 at the time of medical consultation, an abscess developed from the upper part of the right lower leg at venaseal site.Antibiotics (bacta tablet) was re-administered, and drainage of the abscess was performed.On (b)(6) 2023 abscess was gone, but the patient was still under observation because effusion was still coming out.According to physician, it is possible that the ulcer site was infected, resulting in bacteremia, and the venaseal treatment site might have been infected.The patient's condition is improving and is currently under observation.There was still infection at the time of confirmation on (b)(6) 2023.
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Manufacturer Narrative
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Additional information: as of october 31st, there was no problem with pressure on the peripheral side, but there was drainage due to pressure on the central side.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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Additional information: on 2023-11-14, about 10 cm of the place infected with glue was removed.The patient is currently under observation.Still image evaluation: three images were provided for evaluation.The images provided were not of the patient condition/procedure.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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