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Catalog Number VS-402 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Foreign Body Reaction (1868); Skin Discoloration (2074); Skin Irritation (2076); Swelling (2091); Discomfort (2330)
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Event Date 10/21/2019 |
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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Patient had great saphenous vein (gsv) treated with venaseal.Procedure completed as per ifu.A guidewire was used for insertion of the catheter.Patient returned for follow-up ultrasound 4 days post procedure and showed signs of a rash on legs, abdominal area, and chest.Patient treated with medtrol dose pack, increased prednisone to 40mg and added h2 antagonist, benadryl, and nsaid.The physician has reported rash is improving in lower limbs.
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Manufacturer Narrative
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Additional information: patient spent 4 days as in patient on iv steroids.Patient is now on 30 mg of steroids daily and symptoms have resolved.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: there were no challenges related to catheter tip prior to initial deliver of adhesive.The catheter was 5cm caudal to the saphenofemoral junction (sfj).The vein closed.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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