FDA 483 - Boston Scientific Corp - September 12, 2005

This FDA Form 483 details observations from an inspection of Boston Scientific Corporation, specifically involving the Complaint Call Center, Complaint Management Centers (CMC), and the Complaint Investigation Site (manufacturing site).

**Observation 1** identifies a failure to submit Medical Device Reports (MDRs) within the required 30 days. Boston Scientific Corporation determined 13 complaints were MDR reportable, but the reports were filed between 45 and 192 days after initial complaint notification. This indicates a delay in reporting serious device malfunctions.

**Observation 2** highlights inadequate evaluation and investigation of complaints. a) The LeVeen Needle Electrode recall investigation was incomplete, as BSC Spencer, the manufacturer, was unaware of the recall, preventing a complete investigation of both the electrode and the associated RF generator. b) For 7 of 15 LeVeen Electrode recall complaints (Part #M001262160 and M001262170), the device was not returned, and the lot number was not provided, leading to incomplete investigations and a lack of trending analysis by product number.

**Observation 3** notes incomplete complaint handling procedures. Procedure #90101079, "BSC Spencer External Customer Complaint Process," does not identify all trending types for failure analysis. Specifically, trending by product part number was not performed for 7 LeVeen Electrode recall complaints where lot numbers were unavailable, and