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

Model Number	M00532190
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Furthermore, we are unable to provide the complete unique identifier (udi) # as the product is unknown at this time.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the reportable event of surgical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted to treat an obstruction caused by stones in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Post procedure, the patient underwent a laparoscopic cholecystectomy procedure due to stent migration in the cbd wall, and the physician observed that the stent curled and had perforated through the bile duct.The physician rectified the perforation during the procedure.Although the stent was believed to be explanted during laparoscopic cholecystectomy, definitive confirmation remains unknown.There were no patient complications reported, and the patient has fully recovered after the procedure.

• 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 ; AS 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 23057708
• Report Number: 3005099803-2025-04453
• Device Sequence Number: 9225671
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: (01)08714729786986
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101786
• 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
• Report Date (Section B): 09/15/2025

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: M00532190
• Device Catalogue Number: M00532190
• 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: 08/20/2025
• Initial Report FDA Received Date: 09/15/2025
• 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