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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
Vasoconstriction (2126); Thrombosis/Thrombus (4440)
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Event Date 02/19/2024 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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On (b)(6) 2024 a physician used a venaseal closure system during patient treatment.The ifu (instruction for use) was followed during catheter preparation, procedure, post-procedure.The catheter lumen was flushed prior to use.A guidewire was used during catheter insertion and placement.A spasm was formed up to sapheno-femoral junction (sfj), and the blood vessel diameter was narrow.Treatment was performed at a distance of 5 cm according to ifu.After the treatment, it was observed that the glue had extended to femoral vein (fv) when checked with the echocardiogram.Approximately egit class 3 was reported.Precautions were taken, and at the time of the day trip, hospitalization was done and patient was kept under observation.On the following day, a thrombosis was observed around the extended glue, so on (b)(6) 2024 the extended thrombus was ligated under general anesthesia and the thrombus removed.
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Manufacturer Narrative
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Additional information: compression of the gsv was applied.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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