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

Model Number	M00534700
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date of event provided which is june-2025.Block h6: imdrf patient code e2401 captures the reportable event of other serious or important medical events.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted during a stent placement procedure performed on an unknown date.During the procedure, the little plastic blue piece at the end of the wire broke off, and the stent did not deploy.It was also indicated that other serious or important medical events were considered outcomes attributed to the adverse event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted during a stent placement procedure performed on an unknown date.During the procedure, the little plastic blue piece at the end of the wire broke off, and the stent did not deploy.It was also indicated that other serious or important medical events were considered outcomes attributed to the adverse event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
H1 (related report number) was corrected to include the medwatch number.B3: approximated based on the date of event provided which is (b)(6) 2025.H6: imdrf patient code e2401 captures the reportable event of other serious or important medical events.

• 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: 22719736
• Report Number: 3005099803-2025-03857
• Device Sequence Number: 21133917
• Product Code: FGE
• UDI-Device Identifier: 08714729787259
• UDI-Public: (01)08714729787259(17)260731(10)34701732
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: M00534700
• Device Catalogue Number: M00534700
• Device Lot Number: 0034701732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 11/23/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 07/31/2024
• 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: Other
• Patient Sex: Unknown