CRE PRO
Received Jul 8, 2026 · Event occurred Jun 9, 2026
Report 3005099803-2026-02730 · MDR key 25756432
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M00558710Catalog number
M00558710
Lot number
0037787269
Product problems
- Burst Container or Vessel
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE BALLOON WAS PASSED DOWN SCOPE, THE BALLOON BURST AFTER REACHING A DIAMETER OF 20MM. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DASE. 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.