NAVIFLEX? PUSHER

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A2101 CAPTURES THE REPORTABLE EVENT OF DEVICE LABELLING ISSUE. BLOCK H11: INVESTIGATION RESULTS: BASED ON THE INFORMATION AVAILABLE, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF DEVICE LABELLING ISSUE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED TO IDENTIFY ANY POTENTIAL DEVICE DEFECT. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. AS A RESULT, AND DUE TO THE LACK OF AVAILABLE EVIDENCE, BOSTON SCIENTIFIC WAS UNABLE TO CONFIRM THE REPORTED EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF MANUFACTURING DEFICIENCY. BOSTON SCIENTIFIC HAS BEEN NOTIFIED THAT THE ADVANIX PANCREATIC STENT NAVIFLEX LONG WIRE PUSHER (UPN: M00535030) CONTAINED A PUSHER COMPONENT THAT WAS INCONSISTENT WITH THE PRODUCT LABELING. A SHIP HOLD HAS BEEN PLACED ON THE LOT ASSOCIATED WITH THIS COMPLAINT DEVICE. BOSTON SCIENTIFIC HAS ALSO INITIATED A NON-CONFORMING EVENTS PREVENTION (NCEP) INVESTIGATION TO FURTHER EVALUATE THE REPORTED EVENT, AND DETERMINE APPROPRIATE ACTIONS.

Description of Event or Problem

NOTE: RELATED NAVIFLEX LONG WIRE PUSHER COMPLAINTS ARE REPORTED UNDER RECORDS (B)(4), AND (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX LONG WIRE PUSHER WAS USED IN THE PANCREAS TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. A LABELING DISCREPANCY WAS IDENTIFIED: THE PACKAGE WAS LABELED AS A LONG WIRE PUSHER; HOWEVER, THE DEVICE INSIDE WAS A SHORT WIRE PUSHER. DESPITE THIS DISCREPANCY, THE PHYSICIAN USED THE SHORT WIRE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.