Opinion ID: 223134
Heading Depth: 3
Heading Rank: 2

Heading: Express2 Phase Two: A New Design Specification

Text: Although BSC determined that a recall was not necessary, it nevertheless decided to further investigate the no-deflate issue. Internal correspondence from this period shows that the no-deflate issue was seen by some in the company as urgent and a severe compliance risk. So in Galway, a six sigma team was initiated on May 28, 2003 to investigate the cause of focal necking. [6] In addition, following up on the CAPA investigation's finding that the material properties of the distal outer shaft could contribute to the robustness of the proximal balloon weld, BSC created a team in Maple Grovewhere the distal outer shafts had been found to be more robust to develop a new design specification for the distal outer. Over the next four months, the Maple Grove team developed a proposal that focused on the elongation properties of the distal outer. Elongation served as an indirect measure of the molecular orientation and crystallinity of the polymer material used in the distal outer. By setting a length that the distal outer could be stretched before breaking, BSC aimed to ensure that each of its distal outers had material properties that would increase its robustness to subsequent thermal processing that occurs when the outer is laser welded to the balloon component of the delivery system. On October 3, 2003, BSC filed a supplement to its Express2 Premarket Approval (PMA) with the FDA, seeking permission to implement a test method to evaluate the elongation property of the extruded distal outer shaft component for the Express2. In this document, BSC stated that the change was meant to address no-deflate complaints. BSC disclosed that it had received a small number of field complaints (approximately 0.0148% complaint rate) regarding the delivery system balloon's failure to deflate and provided a table listing the no-deflates by month and manufacturing site for January through August 2003. It explained that although it had been unable to definitively confirm the root cause of the failure, its investigation had determined that at least part of the root cause is due to inconsistent material properties of the distal outer shaft component, and that the new design specification was intended (1) to improve the robustness of the distal outer shaft, and (2) to improve the consistency between distal outer shafts manufactured at BSC's [Maple Grove and Galway] facilities. Finally, BSC notified the FDA in this supplement of all of the May 2003 corrective actions that it had taken, explaining its determination that these changes did not require FDA approval. It also reported on the success of these measures, noting that the fifteen no-deflate complaints for Express2 devices that it had received between May and August 2003 were for devices built prior to the implementation of the changes. The FDA approved BSC's request on October 24, 2003.