NAVIFLEX? PUSHER

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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 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 OPENED HAD A SIDE-HOLE FEATURE. THERE WAS NO PATIENT INVOLVEMENT.