Safety Alert for Product Trade Name: Zero TipTM Basket for Calculation Recovery. N. Anvisa Reg.: 10341350264

Safety alert

820

2006-01-16

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The boston scientific corporation is initiating recall of the product calculation recovery basket 1.9 fr zero tip due to having received some complaints in which the recovery basket yarn has detached from the central guide. this has determined that there is a potential risk of the recovery basket wire detaching from the central guide. release of the recovery basket yarn may result in an unsuccessful attempt to remove the calculation or the detached portion may be left inside the patient. if the release of the recovery basket wire occurs and is left inside the patient, a prolonged procedure or possible surgical intervention may be necessary. according to the company, only the codes and lots listed in annex a have been affected by this recall. no other boston scientific product is involved in this medical product recall. boston scientific of brazil reports that, according to the capa - corrective action and preventive action report of the corporation, the failure occurred due to a change in the bonding and pressing processes in the product assembly. boston of brazil states that lots of the affected products were sold only to a single customer, instrumental científico ltda / brasília, and there have been no reports of any such incidents in brazil so far. the company informs that brazil received only 11 batches of the affected product. note: to access annex a with affected lots, go to the following electronic address: http://www.Anvisa.Gov.Br/tecnovigilancia/alertas/anexos_2006/820.Pdf.

The company notified the event to the FDA, as well as Anvisa; - Boston do Brasil reports that the only customer who received units of batches of the affected products has already been notified, saying that the 15 units received were used successfully. These 15 units correspond to 4 different lots. - The 56 units that are in the quarantine area of ​​the stock of the company Boston of Brazil will be referred to the Distribution Center of Boston Scientific Corporation of Quincy. According to the Boston Company of Brazil, the preventive and corrective actions to be taken by the manufacturing company are: - The workers of the production line will be re-trained in the processes of sticking and pressing; - A pull test will be implemented for 100% of the units produced in the assembly process in the period of 4-6 weeks; - The Standard Operating Procedure (POP) for the assembly of this product will contain the following phrases: "Apply adhesive to the mark of the joint until complete filling of the mark."; "Let adhesive glue enjoy for at least 2 seconds"; - The current presses will be replaced by presses connected to a control box that will monitor and control the operation, which will avoid variations in the pressing process. Also, if the process is out of standard an alarm will sound; - A visual inspection of the products will be carried out to verify the presence of glue; - Meetings with workers to discuss product complaints received; - Revision of the general operations instructions with the workers; - A certification of 3 lots will be created for training the operators when the process is finished and the appropriate changes implemented in the general operations instructions. - Although the company has only commercialized the product for only one customer in Brazil, the company is making fax number (11) 5502-8508, Mrs. Lílian Garcia Orofino, in case there is need of contact with the company. INFORMATION UPDATED ON 05/06/2006: A BRAZILIAN SCIENTIFIC BOOKS INFORMED THAT THE FOLLOWING PREVENTIVE ACTIONS WERE TAKEN: 1) FINAL PHYSICAL STUDY TEST WAS IMPLEMENTED TO DETECT FAILURES IN THE PROCESS; 2) NEW FORM FOR THE PRESSURE PROCEDURE. HOW CORRECTIVE ACTIONS FOCUS: 1) ADDITIONAL TEST TO EVALUATE THE SUB-ASSEMBLY OF CENTRAL GUIDE AND RECOVERY BASKET; 2) REPLACEMENT OF THE PRESSORS BY PRESSORS CONNECTED TO A CONTROL BOX MONITORING AND CONTROLLING THE OPERATION, WHICH PREVENTS VARIATIONS IN THE PRESSURE PROCESS, AND SOUND ALARM SO IF THE PROCESS IS OUTSIDE OF THE PATTERNS; 3) THE POP FOR PRODUCT ASSEMBLY HAS BEEN UPDATED WITH THE FOLLOWING PHRASES: "APPLY ADHESIVE TAIL IN THE JUNCTION MARK UNTIL FULL BRACKET FILLING"; "LET ADHESIVE TAIL TAIL FOR AT LEAST 2 SECONDS; 4) THE PRODUCTION LINE OPERATORS WERE RE-TRAINED IN COLLAGE AND PRESSURE PROCESSES; 5) VISUAL INSPECTION TO VERIFY TAIL PRESENCE.