Recipient: Boston Scientific Corp.
Product:Vaxcel Low Profile Infusion Ports, Taxus paclitaxel drug eluting stents and Symmetry balloon dilation catheters
Date: 8/10/05
Failure to analyze processes, work operations and other sources of quality data to identify existing and potential causes of non-conforming product as required by 21 CFR 820.100(a)(1). For example, we observed the release and actual shipment of _____ non-conforming medical devices, specifically _____ units of the Taxus Express 2, Monorail, Paclitaxel-Eluting Coronary Stent System to 5 separate hospitals on January 20 and 21, 2005. These devices had failed the kinetic drug release test results and were part of a “shipping hold”. Through a failure of your quality system, two employees were able to override your computer system, removing the “S-block” to release these devices electronically. These devices were physically removed from a quarantined area and subsequently shipped to 5 separate hospitals. As part of your review of this serious event, you initiated a Product Inquiry Report, (PIR) 2005-01-01. The medical/ clinical assessment of this event your firm indicated that the probability of detecting this event was “high”. Yet the rationale for this detection level stated, “While visual control through the implanting physician will not allow any detection of the occurrence (these stents are visually indistinguishable from the stents within spec), the established KDR controls will continue to provide a high chance to detect outliers before distribution”. We note that this assessment went through your review and approval process. You listed a detection level as “high”, however, your own rationale states that the actual failed stents are visually indistinguishable from stents within specification. Moreover, you stated that the KDR controls provide a high chance to detect outliers before distribution; however, the _____ units actually shipped had failed KDR testing.
For example, BSC CAR-05-004 which involved the shipment of _____ units of failed Taxus Express 2, Monorail, Paclitaxel-Eluting Coronary Stent System, to 5 separate hospitals. This CAPA only states, “Taxus Express 2 product part number H7493897012250, Batch _____ was removed by an operator from a QA quarantined location for shipping. The skid containing these units was labeled ‘Pending KDR Test Results’ and was also `S’ blocked in SAP. A second operator performed an SAP transaction removing the `S’ block status. This resulted in the units to ship to customers.” The CAPA did not include the dates of these serious occurrences, the employees involved, or the number of instances that product was actually either removed from quarantine of overridden in the computer system (SAP). The CAPA also did not list the number of units that were actually shipped, or the number of hospitals that actually received non conforming product. We learned through interviews with employees, that there were actually 5 separate removal actions of Taxus product from the quarantined area. On January 12, 2005 _____ separate batches of Taxus product were removed from the quarantined area. These were caught by an employee; however, a CAPA was not generated for the incident. Actual shipment of the _____ units occurred on January 20 and 21, 2005 when it was realized there was a 5th removal of Taxus from quarantine. The CAPA for this instance was initiated on January 27, 2005.
FDA District: New England District Office
