CRE PRO
Received Jul 31, 2026 · Event occurred Jul 7, 2026
Report 3005099803-2026-03121 · MDR key 50102445
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M00558650Catalog number
M00558650
Lot number
0038143501
Product problems
- Material Split, Cut or Torn
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 to treat common bile duct stone performed on (b)(6) 2026. During the procedure, the balloon was ripped. The procedure was completed using another CRE PRO Wireguided Dilatation Balloon. There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block H6:IMDRF Device Code A0414 captures the reportable event of a balloon torn.