CRE Fixed Wire
Received Jul 31, 2026 · Event occurred Jul 9, 2026
Report 3005099803-2026-03106 · MDR key 50094416
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationModel number
M00558380Catalog number
M00558380
Lot number
0039128386
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 Fixed Wire Dilatation Balloon was attempted to be used during an Esophagogastroduodenoscopy (EGD) procedure for trouble swallowing performed on (b)(6)2026.During the procedure, the balloon was inserted into the scope and inflated to 18mm. The balloon subsequently popped while inflated. No further information has been obtained despite good faith efforts. The procedure was completed with another CRE Fixed Wire Dilatation Balloon.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.
Additional Manufacturer Narrative
Block H6:IMDRF Device Code A0402 captures the reportable event of balloon burst.