MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Advanix? Biliary; Catheter, Biliary, Diagnostic

Model Number	M00534290
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was to be implanted in the common bile duct to treat a biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During deployment of a plastic biliary stent into the left hepatic system, the stent was advanced and positioned as intended.The delivery system pullwire was retracted completely until the hard stop was reached, and the stent was able to be fully deployed.The guidewire was then subsequently removed.However, the suture loop did not release from the delivery system and became wrapped around the stent flange.As the delivery system was withdrawn, the attached suture loop pulled the stent out of the duct.Troubleshooting was performed to free the retained suture loop.Initial attempts to cut the suture using forceps were unsuccessful.A spybite device was then used to successfully cut the suture loop, releasing the stent from the delivery system.Following release, a rat-tooth forceps was used in an attempt to reposition the stent back into the duct; however, repositioning was unsuccessful.The stent was subsequently removed using the rat-tooth forceps.A second stent was unable to be placed because it was not possible to cannulate next to the first stent.The procedure was not completed.There were no adverse event reported due to this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h11: investigation results: based on all available information, boston scientific corporation was unable to confirm the reported events of the stent difficult to position, suture deployment issue and cancelled/rescheduled - post sedation/sedation unknown.The complaint device was not returned; therefore, product analysis could not be performed.Taking all available information into consideration the investigation findings did not lead to a definitive conclusion regarding the cause of the reported events.Without proper evaluation of the device, the most probable contributing cause remains unknown.Device history records 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.Similar complaint review: a similar complaint review was completed.There were no emerging trends identified that warrant further action.Device technical analysis: the complaint device was not returned; therefore, product analysis could not be performed.Risk review: a risk review was completed and confirmed that the reported event of cancelled/rescheduled - post sedation/sedation unknown 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 based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: Advanix? Biliary
• Common Device Name: Catheter, Biliary, Diagnostic
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50673194
• Report Number: 3005099803-2026-03666
• Device Sequence Number: 13305546
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: (01)08714729787389(17)280517(10)39398710
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K203162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: M00534290
• Device Catalogue Number: M00534290
• Device Lot Number: 0039398710
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 05/18/2026
• 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