Background

A high offset in sterile packaging may be seen with large animal implant catheters that were manufactured prior to May 2016, as of the most recent occurrence of the issue. The offset value can range from 30 mmHg to 60 mmHg or more while still in its packaging. After the implant package is opened and catheter tip is removed, the pressure value will return to normal.

This high offset while in the packaging is due to thickened gel in the catheter tip cover. The gel thickening is a result of a chemical reaction, called cross-linking, which occurs during the manufacturing process and is induced by uncured adhesive in the extended tip cover.

Resolution

To prevent this, modifications have been made to the tip cover used in large animal catheters, as well as the manufacturing process. The likelihood of cross-linking and high offsets is low, but there is still potential for it to re-occur.

Should this occur, remove the tip cover and recheck the pressure offset. If the offset remains elevated, please contact DSI Technical Support.