ADMIRAL XTREME OTW

Description of Event or Problem

It was reported that during percutaneous transluminal angioplasty of a venous lesion at the right innominate to superior vena cava junction using catheter In.Pact Admiral balloon, the balloon burst during balloon inflation. The balloon was initially inflated at 6 atm without issue and then burst at nominal 8 atm in less than 1 minute. A balloon tear was observed after withdrawal. Venography was performed after the event, and no fragments were reported. The device was prepped per the instructions for use with no issues identified, and there was no packaging damage, no issues removing the device from the hoop/tray, no resistance encountered when advancing the device, and no excessive force used. The case was finished using a 12 mm Admiral Extreme balloon. No patient symptoms, complications, or injury were reported, and the patient outcome was reported as alive with no injury. No patient complications have been r eported as a result of this 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.