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

Model Number	M00534350
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was to be implanted to treat a bile duct drainage in the main bile duct during a bile duct drainage procedure performed on (b)(6) 2025.During the procedure, difficulty was encountered while introducing the stent into the operating channel.Despite the orange protective cover being in place over the ergos, the device could not be advanced.During the attempt, one of the wires detached and became lodged inside the operating channel.Another advanix biliary stent with naviflex delivery system was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent barb was torn.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h11: an advanix naviflex biliary stent, only the stent was returned for analysis.A media inspection of the photo provided by the complainant noted that there is no visible damage observed in the supplied image.A visual examination of the returned device revealed that one of the stent barbs was slightly torn, and the stent suture hole exhibited tearing.Microscopic examination was performed, confirming localized tearing at the barb and suture hole without additional structural abnormalities.No other damages were noted to the stent product analysis could not confirmed the reported event of device guidewire stuck and stent difficult to advance.As only the stent was returned for evaluation.Taking all available information into consideration, the investigation concluded that the reported event and observed damages to the stent were most likely related to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.The returned stent identified that one of the stent barbs was slightly torn, and the stent suture hole was torn.As the delivery system was not returned, it was not possible to determine whether any damage or malfunction of that component contributed to the reported difficulty in advancing the stent or the guidewire becoming stuck.Additionally, the events occurred during the procedure, and no evidence was available to confirm a device-related cause.Therefore, a review and analysis of the all the available information indicated that the most probable cause is caused not established.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Investigation summary: based on the available information, boston scientific corporation concludes that device guidewire stuck and stent difficult to advance could not be confirmed.Only the stent was returned for evaluation.The investigation concluded that the additional observed damages to the stent were most likely related to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.The returned stent identified that one of the stent barbs was slightly torn, and the stent suture hole was torn.As the delivery system was not returned, it was not possible to determine whether any damage or malfunction of that component contributed to the reported difficulty in advancing the stent or the guidewire becoming stuck.Additionally, the events occurred during the procedure, and no evidence was available to confirm a device-related cause.Therefore, a review and analysis of all available information indicated the most probable cause is caused not established.Device history records review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: only the advanix naviflex biliary stent was returned for analysis.A media inspection of the photo provided by the complainant identified the stent there was no visible damage observed in the supplied image.A visual and microscopic examination of the returned device revealed that one of the stent barbs was slightly torn, and the stent suture hole exhibited tearing.No other damages were noted to the stent labeling review: a labeling review was performed, and from the information available, there is no evidence that this device was used in a manner inconsistent with the instructions for use (ifu)/product label.Risk review: a review of the advanix naviflex biliary stent was completed and confirmed that the of event of stent barb torn.These events type have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a advanix naviflex biliary stent was to be implanted to treat a bile duct drainage in the main bile duct during a bile duct drainage procedure performed on (b)(6) 2025.During the procedure, difficulty was encountered while introducing the stent into the operating channel.Despite the orange protective cover being in place over the ergos, the device could not be advanced.During the attempt, one of the wires detached and became lodged inside the operating channel.Another advanix biliary stent with naviflex delivery system was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent barb was torn.Please see block h11 for 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24115751
• Report Number: 3005099803-2026-00239
• Device Sequence Number: 17661247
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: (01)08714729787440(17)270113(10)35718945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/24/2026

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: M00534350
• Device Catalogue Number: M00534350
• Device Lot Number: 0035718945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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