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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was implanted in the bile duct to treat two large stones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During procedure, the advanix stent did not deploy.The tech pulled back on pull wire, but it did not release.Tech pulled the pullwire back further and felt a snap.The physician then manipulated the scope, and the stent was able to be deployed.Scope was removed from the patient and was inserted back to visualize the stent.However, it was noted that the stent had migrated into the bile duct.Fluoroscopy had poor imaging during the entire procedure and the physician was unable to use fluoroscopy at the conclusion of the procedure to assess stent location as the fluoroscopy screen was not functioning properly.The procedure was completed, and the patient is coming back in two weeks for repeat stent and stone removal.There were no patient complications reported as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22014858
• Report Number: 3005099803-2025-02163
• Device Sequence Number: 18116021
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: (01)08714729787433(17)260720(10)34639745
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 07/20/2026
• Device Model Number: M00534340
• Device Catalogue Number: M00534340
• Device Lot Number: 0034639745
• 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: 04/22/2025
• Initial Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 07/20/2024
• 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: 86 YR
• Patient Sex: Female