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

Model Number	M00553640
Medical Device Problem Codes	Positioning Failure (1158); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
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 all the available information, boston scientific corporation did not confirm the reported events of stent failure to deploy nor handle connection issue.There were no problems detected during the product evaluations of the device.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: an axios stent and electrocautery-enhanced delivery system was returned for evaluation.A visual inspection was performed.The stent was returned fully covered and undeployed.The delivery system was returned in its original position.A functional inspection was performed, the luer lock was connected to the scope and locked correctly, with no issues observed during connection.Additionally, the deployment function was evaluated by sliding the catheter lock to the right and moving the catheter control hub up and down.The catheter passed through the luer without resistance.The stent hub was moved to the second and fourth positions, and the stent was deployed without issues.No resistance was observed during deployment.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 a through review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was to be implanted to treat a pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2023.During the procedure, the physician was unable to properly perform the initial step to tent the tissue due to difficulty attaching the handle to the eus scope using the luer lock.The stent was not deployed, and it was retrieved fully covered by the outer sheath.The procedure was completed using another of the same device 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 ; 9145716918
• MDR Report Key: 25144407
• Report Number: 3005099803-2026-01803
• Device Sequence Number: 9316112
• Product Code: KNS
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)240404(10)29169346
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: M00553640
• Device Catalogue Number: M00553640
• Device Lot Number: 0029169346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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