MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Axios?; gallbladder drainage stent and delivery system

Model Number	M00553640
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
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 intended to be implanted in the gallbladder to treat cholecystitis during an endoscopic ultrasound gallbladder drainage procedure performed on (b)(6)2026.During the procedure, the physician reported that the stent failed to deploy.The procedure was able to be completed by using another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the entire handle was rotated.However, the hot axios stent and delivery system instructions for use state "rotate the winged luer lock clockwise to secure the delivery system handle to the echoendoscope." the physician did not follow the steps cited in the instructions for use (ifu).Note: it was reported that the size of the scope used was 3.2 mm working channel.However, per the axios stent and electrocautery- enhanced delivery system instructions for use, the working channel of the scope should be 3.7mm or larger.The stent is not compatible with a scope with a working channel size of 3.2 mm.
Additional Manufacturer Narrative
Lock h6: imdrf device code a150201 captures the reportable event of stent failure to deploy.

• Brand Name: Axios?
• Common Device Name: gallbladder drainage stent and delivery system
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; ballybrit business park; galway H91 Y 868; EI H91 Y868
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50868657
• Report Number: 3005099803-2026-03914
• Device Sequence Number: 10690552
• Product Code: QXH
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)280317(10)38862365
• 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
• Report Date (Section B): 09/23/2026

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: 0038862365
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 03/18/2026
• 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