CRE PRO

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF FOUR CRE PRO WIREGUIDED DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR CRE PRO WIREGUIDED DILATATION BALLOON WERE ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE BALLOON PUNCTURED ON FIRST USE. THE SAME PROBLEM WAS ALSO ENCOUNTERED WITH THE OTHER THREE CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE TYPE OF PROCEDURE AND THE ANATOMY LOCATION OF THE PROCEDURE ARE UNKNOWN, AND IT IS BEING REPORTED AS THE PINHOLE MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF A BALLOON PINHOLE IN AN UNKNOWN ANATOMY LOCATION.