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

Model Number	M00533380
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.We've sent good faith effort attempts to obtain all missing information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f08 captures the reportable event of hospitalization.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted in the duodenum during a procedure performed on an unknown date.The physician informed that a patient suffered a duodenal perforation after placing the advanix biliary stent the patient was hospitalized.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted in the duodenum during a procedure performed on an unknown date.The physician informed that the patient suffered a duodenal perforation after placing the advanix biliary stent the patient was hospitalized.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.We've sent good faith effort attempts to obtain all missing information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f08 captures the reportable event of hospitalization.Block h11: investigation results: based on the information available, boston scientific was unable to confirm the reported adverse event of a perforation.The device was not returned for analysis; therefore, a technical analysis could not be performed.However, perforation is noted within the instructions for use (ifu) as a potential adverse event associated with the use of the device.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.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Additionally, perforation is noted within the ifu as a potential adverse event associated with the use of the device.Risk review: a risk review was completed and confirmed that the events of perforation, hospitalization or prolonged hospitalization and serious injury/ illness/ impairment were 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 known inherent risk of device.

• 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: 24532402
• Report Number: 3005099803-2026-00852
• Device Sequence Number: 10372214
• Product Code: FGE
• UDI-Device Identifier: 08714729786757
• UDI-Public: (01)08714729786757
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00533380
• Device Catalogue Number: M00533380
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown