EUPHORA RX

Description of Event or Problem

During a procedure an attempt was made to use one Euphora balloon catheter 2.0 x 10 mm when the balloon burst during stent deployment. It was also reported that a Euphora balloon catheter 1.5 x 6.0 mm shaft fractured within the coronary artery with a fragment remaining in place that was removed through intervention. The device was inspected with no issues. No further patient complications were reported as a result of the event.

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.