FLEXIMA PLUS BILIARY

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF CATHETER GUIDE BREAK.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO FLEXIMA PLUS BILIARY STENT USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SUBSEQUENT FLEXIMA PLUS BILIARY STENT WERE TO BE IMPLANTED IN THE BILE DUCT TO TREAT A STENOSIS DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT OF THE REPORTED STENTS IMPEDING DEPLOYMENT, AND BOTH DEVICES INNER CATHETER ULTIMATELY BROKE. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE BECAUSE THE HOSPITAL RAN OUT-OF-STOCK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.