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

Model Number	M00553650
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that two axios stent and electrocautery enhanced delivery system were intended to be implanted transduodenal to treat pancreatic pseudocyst during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2024.During the procedure, the physician reported that the axios stent had heavy resistance when deploying the first flange and the handle broke (subject of this report).Additionally, the physician removed the stent from the scope and tried a new axios stent but had the same outcome.The stent was removed fully covered by the outer sheath and the procedure was able to be completed by using another of the same device (3rd 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: with all available information, boston scientific corporation concludes that the reported event of stent failure to deploy was able to be confirmed.However, the reported events of delivery system difficult to advance and handle break could not be confirmed.The device has been returned with the stent fully cover and undeployed.The reported events of delivery system difficult to advance and handle break are related to the procedure, as there was not objective evidence to confirm the reported failure.Additionally, during evaluation, torsion (rotational damage) and the sheath was found twisted (outer sheath); these damages could have unable to deploy the stent during the procedure.Device technical analysis: an axios stent and electrocautery-enhanced delivery system was received for analysis.The device returned with the stent fully cover and undeployed, therefore the functional inspection related to the deployment of the stent was performed and the catheter was unlocked moving the catheter lock by sliding it to the right, then the catheter control hub was moved up and down.However, the stent was unable to be deployed.It was necessary to disassemble the delivery system to identify the torsion (rotational damage) and the sheath was found twisted (outer sheath).Device history record (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.Instructions for use (ifu)/label review: a labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use/product label."rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope"; however, the sheath was found twisted.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.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: taking all available information into consideration, the investigation concluded that the most probable cause is 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: 25144864
• Report Number: 3005099803-2026-01825
• Device Sequence Number: 9379044
• Product Code: KNS
• UDI-Device Identifier: 08714729904595
• UDI-Public: (01)08714729904595(17)260130(10)33324864
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 01/30/2026
• Device Model Number: M00553650
• Device Catalogue Number: M00553650
• Device Lot Number: 0033324864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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