MalfunctionFGE
CRE PRO
Received Jul 28, 2026 · Event occurred May 1, 2026
Report 3005099803-2026-03060 · MDR key 50056046
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
M00558710Catalog number
M00558710
Lot number
0036176376
Product problems
- Inflation Problem
- Leak/Splash
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions