When a test on whether the balloon system pops after 10 days fails for a device such as ReShape Integrated Dual Balloon System it creates a stir in the office. I would like to share my experience on when a test fails in the medical industry for a different device. I work in company that is known for their product of IABs (intra-aortic balloons). I got involved in a CAPA which claimed that an IAB was leaking. For a FDA class three device to get a complaint on the balloon leaking it means that all the documents associated with this device have to be revised. But that is not the main concern, its actually trying to figure out whether or not the balloons are leaking and if they are then why. The engineers will run numerous tests using pressure gages to analyze numerous amounts of IAB’s. If the realize there are leaks then they have to figure out a way to stop it. If there are no leaks then they have to statistically prove that the product is safe. These steps include research, testing and evaluating. The project manager is required to analyze what’s the critical path and budget to figure out an outline to solve the issue on time and within the budget cost. The project manager will modify the Gantt chart to include testing, research, meetings with engineers and sponsors and time to revise all documents.