Opinion ID: 223134
Heading Depth: 3
Heading Rank: 3

Heading: Express2 Phase Three: Reticule Inspection and Laser Shift

Text: At the same time that BSC was implementing the elongation specification, the six sigma team was completing its report on the laser shift. It found that by shifting the location of the laser used to bond the balloon to the distal outer, from .4 mm to .8 mm, focal necking would be prevented, regardless of the settings of the other factors. [7] However, as Peter Delmer, who headed the effort in Galway, stated, an awful lot more work would have to be done in order to implement that solution. The company needed to verify that the change would not introduce new problems and also confirm whether .8 mm was the ideal position, or whether .7 mm would be better. This validation work was assigned to Kevin Griffin, a Process Development Engineer at Maple Grove. On September 2, Griffin created a plan estimating that a proposal could be submitted to the FDA in November. However, he stated even at this time that the plan was a bit optimistic. [8] His team was advised to keep those working on Taxus, a different group, informed because any manufacturing change submitted to the FDA would need to be assessed for its impact to the Taxus PMA. In the following months, the team worked to develop a validation protocol, which involved discussions with various branches of the company, including manufacturing and regulatory. At this point, as of the beginning of the Class Period in November, there had been only two no-deflate complaints for the tens of thousands of Express2 and Taxus devices manufactured at Galway after the introduction of the May 2003 changes, and there had been only three no-deflates ever on Express2 devices manufactured at Maple Grove. Consequently, Paul Weiss, the leader of the no-deflate PIR, concluded on November 26, 2003 that the interim actions have been very effective.