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

Model Number	M00534630
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter's facility address is (b)(6) specialist centre; reported here as the address exceeded character limit for designated field.Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter break.Block h11: an advanix biliary stent was received for analysis.Visual examination of the returned device found the guide catheter was detached, the stent suture hole and push catheter suture hole were torn.Microscopic inspection was performed, and it was found that the stent was damaged.No other damages were noted to the stent and delivery system.The reported event of stent difficult to deploy was confirmed.The returned guide catheter detachment may have been caused by the tortuosity of the procedure, handling of the device, the manipulation or technique used by the physician limited the performance of the device and contributed to the observed problems.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to factors encountered during the procedure.Therefore, the most probable cause of the reported event is adverse event related to procedure.
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 common bile duct during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.The patient's anatomy was tight.During the procedure, the advanix biliary stent was difficult to deploy.Another advanix device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the guide catheter was detached.Please see block h11 for the full investigation details.

• 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: 22030707
• Report Number: 3005099803-2025-02189
• Device Sequence Number: 8160900
• Product Code: FGE
• UDI-Device Identifier: 08714729787181
• UDI-Public: (01)08714729787181(17)261031(10)35276986
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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 Model Number: M00534630
• Device Catalogue Number: M00534630
• Device Lot Number: 0035276986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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
• Patient Sex: Unknown