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

Model Number	M00534350
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.The patient's anatomy was not tight.During the procedure, the pull wire was difficult to retract, and the stent was unable to be released.The nurse attempted to deploy the stent again; however, the pull wire got detached.The procedure was completed using another of the same device there were no patient complications reported as a result of this event.Note: a review of the photo provided by the complainant showed that the pull wire was broken and kinked, and the push catheter was kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.Block h11: an advanix biliary stent with naviflex rx delivery system were received for analysis.Visual inspection found the pull wire was broken and bent, the push catheter was bent, the push catheter suture hole and stent suture hole were torn, the guide catheter was bent, and the suture was not returned as it was detached.Media inspection was performed, and it was observed that the pull wire was bent, the stent was detached, and the push catheter was bent.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported events of stent failure to deploy, pull wire break, push catheter kinked and pull wire kinked.Taking all available information into consideration, the investigation concluded that the reported events and observed damages were likely due to factors encountered during the procedure.It is possible that the tortuosity of the procedure, and the technique used by the physician limited the performance of the device and contributed to the reported events and observed problems.Therefore, the most probable cause of the reported event is adverse event related to procedure 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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.The patient's anatomy was not tight.During the procedure, the pull wire was difficult to retract, and the stent was unable to be released.The nurse attempted to deploy the stent again; however, the pull wire got detached.The procedure was completed using another of the same device there were no patient complications reported as a result of this event.Note: a review of the photo provided by the complainant showed that the pull wire was broken and kinked, and the push catheter was kinked.

• 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: 21753690
• Report Number: 3005099803-2025-01405
• Device Sequence Number: 18682413
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: (01)08714729787440(17)251029(10)32746608
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 06/03/2025

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: 10/29/2025
• Device Model Number: M00534350
• Device Catalogue Number: M00534350
• Device Lot Number: 0032746608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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 Sex: Unknown