Pruitt F3 Carotid Shunt

Description of Event or Problem

During a carotid endarterectomy procedure, the safety balloons did not inflate properly and were prone to failure. Three devices failed during the same procedure: two devices experienced safety balloon rupture, and one device experienced safety balloon leakage, resulting in an inability to achieve proper balloon inflation. No patient injury was reported. No patient injury occurred.Note: This is report 3 of 3 related to the third shunt with safety balloon leakage used in the event.

Additional Manufacturer Narrative

The device has not been received for investigation. Therefore, we could not conclusively determine the root cause of the reported incident. It is possible to damage the safety balloon if the user mishandled the device when removing the safety sleeve or if the sleeve was incorrectly moved in the direction of the stopcock instead of toward the infusion area of the internal carotid lumen. The damage can also occur from overinflation.As stated in the IFU: The sheath should be moved and hang loosely on the infusion area of the distal lumen (away from the stopcock area). When the balloon is inflated sufficiently to occlude the artery there will be a slight distention of the external safety balloon. This is the end-point: STOP INFLATION IMMEDIATELY AT THIS POINT. The external safety balloon should not be inflated. The Production and Traceability Record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event. All quality control tests were completed successfully and met specification.Note: This is report 3 of 3 related to the third shunt with safety balloon leakage used in the event.