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Catalog Number VS-402 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Date 10/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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A 15 cm segment of the gsv of a patient was treated using vena seal.Access was made with introducer placed just below knee due to small vein and tourchous area that was difficult to navigate.Delivery catheter was sent up and injections of venaseal began just below the knee.Procedure was completed without issue.The patient had a late onset (3.5-4 weeks after treatment) of redness and pain.The patient was treated with antibiotics which resolved the symptoms quickly.A second onset of localized redness and itching (pruritus) occurred a few days later.The physician proceeded to place the patient on a solu-medrol dose pack, which has also greatly reduced her symptoms.It was reported the patient may have a "may-thurner" lesion.
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Search Alerts/Recalls
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