CRE PRO
Received Jul 3, 2026 · Event occurred Aug 22, 2025
Report 3005099803-2026-02667 · MDR key 25707131
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M00558710Catalog number
M00558710
Lot number
0036325912
Product problems
- Leak/Splash
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0504 CAPTURES THE REPORTABLE EVENT OF BALLOON LEAK IN AN UNKNOWN ANATOMY LOCATION.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON LEAKED WATER. THE PROCEDURE OUTCOME REMAINS UNKNOWN. 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 LEAK MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.