AXIOS Stent and Electrocautery Enhanced Delivery System
Received Jun 5, 2026 · Event occurred May 8, 2026
Report 3005099803-2026-02325 · MDR key 25410673
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553550Catalog number
M00553550
Lot number
0036995592
Product problems
- Electrical /Electronic Property Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
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 TRANSGASTRIC TO PANCREAS TO TREAT A PANCREATIC PSEUDOCYST DURING AN ULTRASOUND ENDOSCOPY-GUIDED PUNCTURE AND DRAINAGE OF PANCREATIC PSEUDOCYST WITH STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE ELECTRODE WAS CONNECTED, THE PHYSICIAN STEPPED ON THE PEDAL, THE CATHETER COULD NOT BE ADVANCE INTO THE CYSTIC CAVITY AND BLANCHING OF THE TISSUE WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A07 CAPTURES THE REPORTABLE EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY.