AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jun 1, 2026 · Event occurred May 1, 2026
Report 3005099803-2026-02240 · MDR key 25350644
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553550Catalog number
M00553550
Lot number
0038554959
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF CONNECTOR DETACHED.
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 PANCREAS TO TREAT A FLUID MASS DURING A PANCREATIC CYST DRAINAGE PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, UPON REMOVAL OF THE DIATHERMY LEAD, THE COPPER WIRE AND PIN DETACHED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.