ENCORE 26
Received Jul 13, 2026 · Event occurred Jun 16, 2026
Report 3005099803-2026-02795 · MDR key 25807882
Device
Generic name
Syringe, Balloon Inflation
Manufacturer
Boston Scientific CorporationModel number
M00566670Catalog number
M00566670
Lot number
0038304901
Product problems
- Display or Visual Feedback Problem
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENCORE 26 INFLATION WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE BAROMETER MALFUNCTIONED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0902 CAPTURES THE REPORTABLE EVENT OF GAUGE READING INACCURATE.