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

Model Number	M00534710
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
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 implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the guide catheter was broken.However, the procedure was able to be completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Block h11: investigation summary: with all available information, boston scientific corporation did not confirm the reported event of catheter guide break.Product analysis confirmed the guide catheter remained intact and was not detached or broken.The stent and push catheter suture holes were observed to be torn, which is consistent with the application of pressure during an attempted stent deployment.Impeded stent deployment may have contributed to the tearing of the push catheter suture hole.Additionally, the same applied forces may have contributed to tearing of the stent suture hole.The pull wire was observed to be bent with the pull wire cap detached, which is also consistent with device deformation under procedural stress encountered during the deployment attempt.The investigation concluded that the additional device damages are consistent with procedural factors, including lesion characteristics, device handling, and the technique used during the procedure (e.G., force applied).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: an advanix rx biliary stent with naviflex delivery system was returned for analysis.Visual evaluation identified a guidewire within the delivery system, a kinked pull wire, and a detached pull wire cap.Additionally, the push catheter suture hole and the stent suture hole were observed to be torn.A destructive test was performed, confirming that the guide catheter remained within the delivery system and was not detached or broken.No additional damage was observed.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 risk review was completed and confirmed that the event of catheter guide break was defined in the risk documentation.This event type has 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 adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the guide catheter was broken.However, the procedure was able to be completed.There were no patient complications 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24274092
• Report Number: 3005099803-2026-00487
• Device Sequence Number: 10725881
• Product Code: FGE
• UDI-Device Identifier: 08714729787266
• UDI-Public: (01)08714729787266(17)270709(10)37095660
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: M00534710
• Device Catalogue Number: M00534710
• Device Lot Number: 0037095660
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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