CRE PRO

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF BALLOON BURST.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS BEING PREPARED TO BE USED THE PYLORUS DURING AN ENDOSCOPIC BALLOON DILATATION PROCEDURE FOR BENIGN PYLORIC STENOSIS PERFORMED ON (B)(6) 2026. DURING PREPARATION OUTSIDE THE PATIENT, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH CRE PRO WIREGUIDED DASE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED PRIOR TO USE IN THE PROCEDURE. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS PRE-INFLATED OUTSIDE OF THE PATIENT.