MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Axios?; unit, electrosurgical, endoscopic (with or without accessories)

Model Number	M00553650
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a hot axios was to be implanted in the bile duct to treat stones in the bile duct during an endoscopic ultrasound-directed transgastric ercp (edge) procedure performed on (b)(6) 2026.During the procedure, the physician encountered difficulty in deploying the axios second flange.The stent deployed at an incorrect location, and the patient was perforated.The patient then underwent a laparoscopic assisted ercp.The stent was removed, and the perforation was addressed using clips.The patient was reported to be stable following the procedure.Note: it was reported that the axios stent was attempted to be implanted to treat stones in bile duct.However, per the axios stent and electrocautery-enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts equal to or greater than 6 cm in size and walled-off necrosis equal to or greater than 6 cm in size that are adherent to the gastric or bowel wall.The device is not indicated for stones.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f2202 captures the reportable event of the patient underwent laparoscopic assisted ercp.Imdrf impact code f2301 captures the reportable event of perforation was addressed in index procedures using clips.

• Brand Name: Axios?
• Common Device Name: unit, electrosurgical, endoscopic (with or without accessories)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50718904
• Report Number: 3005099803-2026-03709
• Device Sequence Number: 9779315
• Product Code: KNS
• UDI-Device Identifier: 08714729904595
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00553650
• Device Catalogue Number: M00553650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/10/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 228 LB