MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00553660
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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 a drainage procedure performed on (b)(6) 2023.During the procedure, the stent was not able to be deployed.The first step of the deployment process was unachieved.The device was retrieved with the stent fully covered by the outer sheath and the procedure was completed by using another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable event of stent failure to deploy.Block h11: following an update to the axios risk documentation, this event is being reported as part of the efforts associated with boston scientific's nonconforming events and prevention investigation, (b)(4).Investigation result: with the information available, boston scientific corporation concludes that the reported event involving failure of the stent to deploy could not be confirmed.In addition, the manufacturing documentation review did not identify any issues that could be associated with the reported event.Dhr review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the device has not been returned for analysis.Therefore, a technical analysis could not be performed.Risk review: a risk review was completed and confirmed that the event of "stent failure to deploy" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the available information, there is not enough evidence to confirm the reported event.Due to the lack of evidence and without proper evaluation of the complaint device, cause not established is selected as the investigation conclusion code.

• 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 ; 9145716918
• MDR Report Key: 25144402
• Report Number: 3005099803-2026-01784
• Device Sequence Number: 13090273
• Product Code: KNS
• UDI-Device Identifier: 08714729951179
• UDI-Public: (01)08714729951179(17)240525(10)31699883
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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 Expiration Date: 05/25/2024
• Device Model Number: M00553660
• Device Catalogue Number: M00553660
• Device Lot Number: 0031699883
• 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: 07/14/2023
• Initial Report FDA Received Date: 05/11/2026
• Date Device Manufactured: 05/26/2023
• 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