MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS?; GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM

Model Number	M00553640
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
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 implanted in the bile ducts to treat a biliary obstruction trough during a gallbladder drainage during endoscopic ultrasound performed on (b)(6) 2026.During the procedure, the axios successfully deployed but as the inner catheter was being taken out the nose cone of the delivery system, it got hooked on the saddle of the stent and was not able to be removed.The physician attempted to straighten out the scope and get into a better position in order to withdraw but it would not come out of the stent so the physician tried to resheathed the delivery system and advanced the catheter back through the stent which covered the nose cone in order to be removed.At the end, the procedure was successfully completed using the same device.There were no patient complications reported as a result of this event.Note: it was reported that the physician resheathed the stent by trying to reverse the handle back to step one.However, per the instruction for use (ifu) "the stent cannot be resheathed after the stent first flange has been deployed." therefore, the instruction for use were not followed.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.We are unable to provide the device manufacture date.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of delivery system difficult to remove.The device was not returned for analysis; therefore, a technical analysis could not be performed.There is not enough evidence to determine whether the delivery system difficult to remove was due to the physician's device manipulation during the procedure or related to a device malfunction.Good faith effort attempts were made to try and retrieve the device; however, response was not received.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Label review: the labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications."the stent cannot be resheathed after the stent first flange has been deployed"; however, it was reported that the physician resheathed the stent by trying to reverse the handle back to step one.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 "delivery system difficult to remove" 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 cause not established.

• 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 ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24817780
• Report Number: 3005099803-2026-01268
• Device Sequence Number: 9600999
• Product Code: QXH
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/08/2026

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
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/08/2026
• 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