NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER

Description of Event or Problem

It was reported that during a peripheral artery intervention using the NanoCross Elite balloon catheter, a plaque lesion in the mid segment of the left superficial femoral artery was treated in a patient. The vessel had minimal tortuosity and minimal calcification, and the artery diameter was reported as 6 mm. A 6F sheath and a .014 guidewire were used, embolic protection was not used, the vessel was not pre-dilated, and the balloon was inflated with an inflation device using 50/50 contrast. At 10 atm, a balloon twist was reported, and a dog-bone or twist was visible within the balloon in the vessel. The device was safely removed, and the procedure was completed using a new balloon catheter. No health consequences or impact were reported.

Additional Manufacturer Narrative

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.