Spencer IN, dated 08/25/2005 - 09/12/2005
300 River Place, Suite 5900
Detroit, MI 48207
(313) 393-8100 Fax:(313) 393-8139
08/25/2005 - 09/12/2005*
TO: Mr. George Telthorst, General Manager
Boston Scientific Corp
780 Brookside Dr
Spencer, IN 47460-1080
Medical Device Manufacturer
DURING AN INSPECTION OF YOUR FIRM I OBSERVED:
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Specifically, Complaints are received by the Boston Scientific Complaint Call Center, who then forwards the complaint to the appropriate Complaint Management Center (CMC), where an initial MDR determination is completed. The CMC then has the Complaint Investigation Site, the site that manufactured the device, conduct a complaint investigation to determine root cause and search for complaint trends. The following complaints were determined to be MDR reportable by Boston Scientific Corporation, however, the MDR reports were filed more than 30 days after the initial complaint notification.
Complaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary.
- The LeVeen Needle Electrode recall investigation was incomplete. BSC Spencer, the manufacturer of the LeVeen Needle Electrode, which is used as an accessory in conjunction with the Boston Scientific Corporations Radiofrequency (RF) generator for thermal necrosis of soft tissues, was not aware of the LeVeen Needle Electrode recall when the FDA Investigator asked for that specific recall documentation. By not being aware of the LeVeen Needle Electrode recall and the subsequent investigation activities, the firm can not assure that a complete recall investigation was conducted on both the LeVeen Needle Electrode, manufactured at BSC Spencer, and the BSC RF generator. The product investigation report is WAT-2005-04-01. The LeVeen Needle Electrode affected model numbers are M001262160 and M001262170.
- BSC Spencer has the capability to do trending analysis by product lot number and product part number. For 7 of 15 complaints reviewed specific to the Leveen Electrode recall, Part #M001262160 and M001262170, Complaints 656988, 654015, 654019, 654023, 654029, 654032, 654033 the device was not returned and the complainant did not give the lot number. The complaint investigation was incomplete in that the firm did not investigate each complaint completely to identify possible trends. For these seven complaints, the lot number was not available and there was no trending analysis done on the LeVeen product number.
Complaint handling procedures for reviewing and evaluating complaints have not been completed.
Specifically, BSC Spencer External Customer Complaint Process procedure, #90101079 is incomplete in that it does not identify all trending types to be researched during the failure analysis to determine if their are any related complaints. For 7 of 15 complaints reviewed specific to the Leveen Electrode recall, the firm did not do trending by product part number for complaint investigations when the device was not returned and the firm was unable to obtain the product lot number. The complaints were closed after 90 days.
Procedures for the control and distribution of finished devices have not been defined and complete to ensure that only devices approved for release are distributed.
Specifically, when BSC Spencer places a shipping hold on products, they can still ship product from their facility to the BSC Quincy distribution facility "at risk" and on ship hold. The BSC Spencer procedure, Shipping Holds - In-plant and Distribution Holds, Q489027-0A, does not require the firm to hold product at the BSC Spencer facility.
08/25/2005(Thu), 08/26/2005(Fri), 08/29/2005(Mon), 08/30/2005(Tue), 09/02/2005(Fri), 09/06/2005(Tue), 09/09/2005(Fri), 09/12/2005(Mon)
FDA EMPLOYEE'S NAME, TITLE, AND SIGNATURE:
Benjamin J Smith, Investigator
FORM FDA 483 (7/00) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS
The observations of objectional conditions and practices listed on the front of this form are reported:
Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.