CRE PRO
Received Jul 31, 2026 · Event occurred Jul 6, 2026
Report 3005099803-2026-03111 · MDR key 50098110
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M00558610Catalog number
M00558610
Lot number
0037377525
Product problems
- Burst Container or Vessel
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported to Boston Scientific Corporation that a CRE PRO Wireguided Dilatation Balloon was attempted to be used in the ampulla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure for the ampullary dilation performed on (b)(6) 2026.During the procedure, the balloon ruptured. It was reported that no piece of the balloon detached inside the patient. The procedure was completed using another CRE PRO Wireguided Dilatation Balloon. There were no patient complications reported as a result of this event and the patient condition following procedure was reported to be stable.
Additional Manufacturer Narrative
Block H6:IMDRF Device Code A0402 captures the reportable event of a balloon burst.