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

Model Number	M00534650
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	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of forceps was used to release the stent.
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 biliary duct during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the catheter was cracked making it difficult to release the stent.The catheter was held firmly, and forceps was used to release the stent.The stent was successfully deployed, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of forceps was used to release the stent.Block h11: an advanix biliary stent with naviflex rx delivery system were received for analysis.Visual inspection found the pull wire was dislodged and without the pull wire cap, the push catheter suture hole was torn, and the guide catheter was detached as it was not returned.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported events of guide catheter break and stent difficult to deploy.Taking all available information into consideration, the investigation concluded that the observed damage of push catheter suture hole was likely caused by the pressure exerted during the attempted deployment of the stent.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 observed problem.Additionally, since the push catheter suture hole was torn, the suture was most likely stuck in the torn hole, preventing the stent from being deployed.There is also a possibility that the same force applied during the stent deployment attempt caused the pull wire to become dislodged and the pull wire cap to detach from the device.The reported event and observed damage of guide catheter detached was most likely due to the force applied during the procedure, and the tortuosity of the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause 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 implanted in the biliary duct during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the catheter was cracked making it difficult to release the stent.The catheter was held firmly, and forceps was used to release the stent.The stent was successfully deployed, and the procedure was completed.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: 22189142
• Report Number: 3005099803-2025-02680
• Device Sequence Number: 8571181
• Product Code: FGE
• UDI-Device Identifier: 08714729787204
• UDI-Public: (01)08714729787204(17)261112(10)35685721
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203162
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00534650
• Device Catalogue Number: M00534650
• Device Lot Number: 0035685721
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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: Required Intervention
• Patient Sex: Unknown