CLOSUREFAST 6FR CATHETER

Description of Event or Problem

It was reported that a Closurefast Catheter was used during treatment of the distal great saphenous vein in the peripheral vein(s), and coil damage was identified during use in the patient. During treatment, an audible ¿pop¿ sound was heard from the catheter, andthe patient experienced extreme pain at that time. The device was safely removed, and an ultrasound was performed after catheter removal that showed swelling. Local anesthesia and tumescent infiltration were utilized, the lumen was flushed prior to use, and four segments were treated; the vein was reported to have closed. The procedure was aborted.

Additional Manufacturer Narrative

Image Analysis One still image was provided for evaluation. 1st image: The image appears to be a Closurefast catheter element/ heating coil. No signs of FEP/ overheating damage can be seen on the element/ heating coil section. No catheter identifiers are visible to establish that the pictured device is related to the complaint on file The reported event could not be confirmed from the image provided for evaluation. 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.