NAVIFLEX? PUSHER

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A2101 CAPTURES THE REPORTABLE EVENT OF DEVICE LABELING ISSUE.

Description of Event or Problem

NOTE: RELATED NAVIFLEX LONG WIRE PUSHER COMPLAINTS ARE REPORTED UNDER RECORDS (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIFLEX LONG WIRE PUSHER WAS USED IN THE AMPULLA OF VATER AND PANCREATIC DUCT TO TREAT A BILIARY STONE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A LABELING DISCREPANCY WAS IDENTIFIED: THE PACKAGE WAS LABELED AS A LONG WIRE PUSHER; HOWEVER, THE DEVICE INSIDE WAS A SHORT WIRE PUSHER. IT WAS ALSO DETERMINED THAT THE PRODUCT USED HAD A SIDE-HOLE FEATURE. DESPITE THIS DISCREPANCY, THE PHYSICIAN PROCEEDED WITH THE SHORT WIRE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.