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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
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 in the area to perform an axios procedure performed on (b)(6) 2023.During the procedure, the physician encountered difficulty deploying the stent.Although the doctor attempted deployment, the stent did not release, and no deployment was visible under fluoroscopy.The procedure was completed using another axios stent.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 results: an axios stent was received for analysis.Based on the available information, boston scientific was able to confirm the reported event of stent failure to deploy.During the evaluation, torsion (rotational damage) was identified, and the outer sheath was found to be twisted, which is evidence the handle was incorrectly rotated.Device technical analysis: the device was received and a visual inspection was performed.During the product analysis, it was necessary to disassemble the delivery system.Torsion (rotational damage) was identified, and the outer sheath was found to be twisted.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.Labeling review: the labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications."rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope"; however, according to the evidence found in the product analysis, the outer sheath was retuned twisted which is evidence the handle was incorrectly rotated.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Risk review: a risk review was completed and confirmed that the event of "stent failure to deploy" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of failure to follow instructions.

• 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: 25144414
• Report Number: 3005099803-2026-01810
• Device Sequence Number: 9316574
• Product Code: KNS
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)250820(10)32257751
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• 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: 08/20/2025
• Device Model Number: M00553640
• Device Catalogue Number: M00553640
• Device Lot Number: 0032257751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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: Unknown