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

Model Number	M00534630
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a advanix stent with naviflex delivery system was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, while attempted to deploy the stent, the black catheter remained in the stent and the stent was not able to deploy.There were no patient complications as a result of this event.No further information has been obtained despite good faith effort.
Additional Manufacturer Narrative
Blocks e4 (init rptr also sent rep to fda), g2 (report source), and h10 (related report number) were corrected following a review which identified that this complaint was reported via medwatch.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a advanix stent with naviflex delivery system was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on(b)(6) 2025.During the procedure, while attempted to deploy the stent, the black catheter remained in the stent and the stent was not able to deploy.There were no patient complications as a result of this event.No further information has been obtained despite good faith effort.

• 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: 22329539
• Report Number: 3005099803-2025-02862
• Device Sequence Number: 8288609
• Product Code: FGE
• UDI-Device Identifier: 08714729787181
• UDI-Public: (01)08714729787181(17)260719(10)34628918
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K203162
• 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
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2026
• Device Model Number: M00534630
• Device Catalogue Number: M00534630
• Device Lot Number: 0034628918
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 11/23/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 07/19/2024
• 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
• Patient Age: 79 YR
• Patient Sex: Female