CRE PRO

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0504 CAPTURES THE REPORTABLE EVENT OF BALLOON LEAK IN THE ESOPHAGUS.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY WITH DILATATION PROCEDURE FOR ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, AFTER THE BALLOON WAS INTRODUCED THROUGH THE WORKING CHANNEL, THE FIRST TWO DILATION STAGES (18MM AND 19MM) WERE PERFORMED WITHOUT ANY DIFFICULTIES. DURING THE THIRD DILATION STAGE (20 MM), THE BALLOON WAS NO LONGER ABLE TO MAINTAIN THE FLUID DUE TO A POSSIBLE LEAK IN THE DEVICE. THE BALLOON WAS REMOVED AND A SECOND OF THE SAME BALLOON DEVICE WAS ATTEMPTED TO BE USED. HOWEVER, THE SAME PROBLEM OCCURRED WITH THE SECOND BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRD CRE PRO WIREGUIDED DASE DILATATION BALLOON. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.