RELIEVA SCOUT SCT0624MFSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031238039), received between Jan 3, 2018 and Jan 3, 2018 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCLARENT WAS INFORMED ON (B)(6) 2017, OF AN EVENT THAT OCCURRED ON (B)(6) 2017, INVOLVING A RELIEVA SCOUT® MULTI-SINUS DILATION SYSTEM 6 X 24 MM (LOT#: 160809A-PC). DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE PATIENT DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK AFTER THE FIRST INFLATION AT 12 ATM IN THE RIGHT FRONTAL SINUS. THE CSF LEAK WAS PATCHED WITH A MUCOSAL GRAFT AND DURASEAL AND THE FESS PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL AFTER THE PROCEDURE AND WAS REPORTED TO BE DOING WELL AFTER BEING DISCHARGED FROM THE HOSPITAL THE NEXT DAY. IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE CSF LEAK MAY HAVE BEEN CAUSED BY HIS PROBING WITH A SEEKER MORE THAN THE BALLOON INFLATION ITSELF. HOWEVER, THE CAUSE WAS NOT DETERMINED AFTER THE FACT. IT WAS ALSO REPORTED THAT THIS WAS THE FIRST TIME THE PHYSICIAN HAD USED THE RIGID NON-ACCLARENT DEVICE. THE RELIEVA SCOUT® MULTI-SINUS WAS REPORTED TO HAVE FUNCTIONED AS EXPECTED. THERE WERE NO REPORTED MALFUNCTIONS WITH ANY ACCLARENT DEVICES USED DURING THIS PROCEDURE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7162769 ↗