Recipient:Edwards Life Sciences, LLC
Product: Swan-Ganz Continuous Cardiac Output (CCO) Catheter, Vigilance Monitors, and stents
Failure to submit a supplemental report to FDA within 1 month of receipt of information that was known to you regarding a serious injury reportable under 21 CFR 803.50, as required by 21 CFR 803.56. For example,
b) A similar complaint from [redacted] for a CCO catheter that had melted during a procedure on October 9, 2002, was not disclosed in a supplemental report although your firm was aware that a software problem was the root cause of the event.
FDA District: Los Angeles District Office