AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jan 15, 2026 · Event occurred Dec 22, 2025
Report 3005099803-2026-00218 · MDR key 24088648
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553520Catalog number
M00553520
Lot number
0034364663
Product problems
- Failure to Conduct
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER'S CITY IS (B)(6); REPORTED HERE AS THE CITY EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF THE PROCEDURE WAS RE-SCHEDULED
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE DUODENUM DURING AN ENDOSCOPIC ULTRASOUND (EUS) WITH COMMON BILE DUCT DRAINAGE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AXIOS DEVICE CAUTERY FAILED TO DELIVER ENERGY. THE PHYSICIAN DECIDED TO REMOVE THE STENT, AND THE PROCEDURE WAS RE-SCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.