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

Model Number	M00553640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of handle break.Block h11: investigation results: with all available information, boston scientific corporation concludes that the reported event of handle break was not confirmed.There is insufficient evidence to determine whether the reported event was related to physician technique, procedural factors, or a potential device malfunction.Device history record review: it was confirmed that this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis: the complaint device was not returned; therefore, product analysis could not be performed.Investigation conclusion: based on all gathered information, the complaint investigation conclusion code of cause not established was assigned.
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 in the stomach to treat acute pancreatitis during an endoscopy ultrasound procedure performed on (b)(6) 2026.During the procedure, the physician stated that the handle broke during step 2 preventing the stent from being fully released.The physician was able to withdraw the device from the pancreatic cyst and another of the same device was implanted.There were no patient complications reported as a result of this event.

• 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: 25830679
• Report Number: 3005099803-2026-02836
• Device Sequence Number: 10383839
• Product Code: KNS
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)280426(10)39196112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: M00553640
• Device Catalogue Number: M00553640
• Device Lot Number: 0039196112
• Was Device Available for Evaluation?: No
• 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: 06/24/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 04/27/2026
• 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: Unknown