MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX? BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534570
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire and guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required to remove the broken guide catheter.
Event or Problem Description
It was reported that an advanix stent with naviflex delivery system was to be implanted in the distal common bile duct to treat cholangitis caused by a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026 during attempted deployment, the handle was unlocked and the blue pull wire was retracted, along with removal of the guidewire.However, the stent did not deploy and remained attached to the delivery system.The suture remained intact, and further retraction of the blue pull wire was not possible.To prevent potential stent migration from the bile duct, the endoscope elevator was used to stabilize the stent while the delivery system was withdrawn.During withdrawal, the blue pull wire fractured.Upon removal of the white delivery system, it was observed that the black inner catheter remained within the lumen of the stent, preventing disengagement of the suture and separation of the stent from the delivery system.Grasping forceps were used to manually retrieve the black inner catheter while maintaining the stent position within the bile duct.The black inner catheter was successfully removed; however, it subsequently became lodged within the endoscope working channel and required removal.The procedure was completed using the same stent.No patient complications were reported, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Block h6 (device codes) has been corrected.Block h6: imdrf device code a0401 captures the reportable event of pull wire and guide catheter break imdrf impact code f2301 captures the reportable event of additional device required to remove the broken guide catheter.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported events of guide catheter break and pull wire break.The complaint device was not returned as it remains implanted; therefore, product analysis could not be performed.The investigation concluded that there is not enough evidence to determine if the reported events were caused due to the physician's technique during the procedure, or whether it was related to a device malfunction.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.Device technical analysis: the complaint device was not returned as it remains implanted; therefore, product analysis could not be performed.Risk review: a risk review was completed and confirmed that the reported event of guide catheter break and pull wire break 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 unable to exclude device problem.
Event or Problem Description
It was reported that an advanix stent with naviflex delivery system was to be implanted in the distal common bile duct to treat cholangitis caused by a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During attempted deployment, the handle was unlocked and the blue pull wire was retracted along with removal of the guidewire; however, the stent did not deploy and remained connected to the delivery system.The suture remained intact, and the blue pull wire could not be retracted further.To prevent stent migration from the bile duct, the endoscope elevator was used to stabilize the stent while the delivery system was withdrawn.During this process, the blue pull wire snapped.Upon removal of the white delivery system, it was observed that the black inner catheter remained within the stent lumen, preventing disengagement of the suture.Grasping forceps were used to manually retrieve the black inner catheter while maintaining stent position.The black catheter was successfully retrieved but subsequently became lodged within the scope's working channel and required removal.The procedure was able to be completed with the same device.No patient complications were reported, and the patient is expected to fully recover.

• 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 ; 9145716918
• MDR Report Key: 24457830
• Report Number: 3005099803-2026-00749
• Device Sequence Number: 18679024
• Product Code: FGE
• UDI-Device Identifier: 08714729787129
• UDI-Public: (01)08714729787129(17)270507(10)37022128
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203162
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: M00534570
• Device Catalogue Number: M00534570
• Device Lot Number: 0037022128
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 05/07/2025
• 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 Sex: Unknown