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); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was implanted transgastric to the gallbladder to treat cholecystitis during an endoscopic ultrasound (eus)-guided gallbladder drainage procedure performed on (b)(6) 2026.During the procedure, the axios stent was successfully deployed.However, upon removal of the delivery system, resistance was encountered, and the cone of the cautery tip became caught on the distal flange.Subsequently, the inner sheath and tip detached and were removed using rescue forceps.Despite the 15 minutes delay, the procedure was completed.There were no patient complications reported as a result of this event.Note: a photo of the device provided by the complainant showed that the inner sheath was detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.Imdrf device code a0501 captures the reportable event of inner shaft/sheath detachment of device or device component.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf impact code f2301 captures the reportable event of the broken inner sheath was removed using rescue forceps.
Additional Manufacturer Narrative
Block g4 (premarket / 510(k) #) was updated.Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.Imdrf device code a0501 captures the reportable event of inner shaft/sheath detachment of device or device component.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf impact code f2301 captures the reportable event of the broken inner sheath removed using rescue forceps.Block h11: investigation results: based on the available information, boston scientific corporation confirmed the reported event of inner shaft/sheath detachment of device or device component as observed on the media analysis of the provided photographs.The investigation concluded that this damage was most likely caused by procedural factors such as lesion characteristics, handling of the device, the technique used by the physician (force applied).However, the additional reported events of tip damaged/defective and delivery system difficult to remove were not confirmed, without proper evaluation of the device, it is unknown if these events were due to the technique used during the procedure, anatomical conditions or related to device malfunction.Device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.However, media analysis was performed on provided photographs by the complainant, where it can be observed the inner sheath detached.No other problems with the device were noted.Device history record: 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.Risk review: a risk review was completed and confirmed that the events of inner shaft/sheath detachment of device or device component, tip damaged/defective and additional device required were defined in the risk documentation.These event types have 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 adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was implanted transgastric to the gallbladder to treat cholecystitis during an endoscopic ultrasound (eus)-guided gallbladder drainage procedure performed on (b)(6) 2026.During the procedure, the axios stent was successfully deployed.However, upon removal of the delivery system, resistance was encountered, and the cone of the cautery tip became caught on the distal flange.Subsequently, the inner sheath and tip detached and were removed using rescue forceps.Despite the 15 minutes delay, the procedure was completed.There were no patient complications reported as a result of this event.Note: a photo of the device provided by the complainant showed that the inner sheath was detached.

• 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: 24618795
• Report Number: 3005099803-2026-00988
• Device Sequence Number: 21226439
• Product Code: QXH
• UDI-Device Identifier: 08714729904588
• UDI-Public: (01)08714729904588(17)271013(10)37684685
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153088
• 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,Followup
• Report Date (Section B): 04/14/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00553640
• Device Catalogue Number: M00553640
• Device Lot Number: 0037684685
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 10/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White