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

Model Number	M00553650
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was intended to be implanted transgastrically to treat a cyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2026.The procedure went well and as expected until the last step.The axios flange was deployed and in the working channel of the scope, but when the physician pulled the scope back it pulled the stent out of place.The physician believes that the sheath was not completely off of the stent and still keeping it attached.The procedure was able to be completed by using another of the same device.There were no patient complications reported as a result of this event and fully recovered.

• 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: 25661337
• Report Number: 3005099803-2026-02618
• Device Sequence Number: 14852177
• Product Code: KNS
• UDI-Device Identifier: 08714729904595
• UDI-Public: (01)08714729904595(17)280309(10)38797221
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00553650
• Device Catalogue Number: M00553650
• Device Lot Number: 0038797221
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 07/13/2026; Not provided
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/05/2026; 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2026
• 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
• Patient Sex: Male
• Patient Weight: 55 LB