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

Model Number	M00534560
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent with naviflex delivery system was used in the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the introducer broke and was subsequently retrieved using forceps.Due to this issue, the stent could not be deployed.The procedure was completed using another of the same device.There were no patient complications reported as a results of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf device code f2301 captures the reportable event of an additional device required (forceps) to retrieve the broken device.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf device code f2301 captures the reportable event of an additional device required (forceps) to retrieve the broken device.Block h11: investigation results: based on the available information, boston scientific confirmed the reported events of catheter guide break and stent failure to deploy.The reported and observed event of guide catheter detached was most likely due to a random failure at the connection between the pull wire and the guide catheter (hypotube) during the procedure, which also contributed to difficulties in stent deployment.Additionally, the push catheter was observed to be bent.Procedural factors, including device handling and physician technique, likely contributed to the observed damage.The manufacturing team indicates that multiple in-process inspections and functional assembly steps are performed, during which the guide catheter is repeatedly advanced and retracted.These controls would typically identify a fractured pull wire joint, as the device would not function properly if such a condition were present during manufacturing.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the returned advanix biliary stent with naviflex rx delivery system was analyzed.Visual examination confirmed that the push catheter was bent and the guide catheter was detached.Microscopic inspection revealed that the joint between the pull wire and the guide catheter was broken.No other problems with the device were noted.Risk review: a risk review was completed and confirmed that the events of catheter guide break and additional device required were defined in the risk documentation.These event types 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 traced to component failure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent with naviflex delivery system was used in the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the introducer broke and was subsequently retrieved using forceps.Due to this issue, the stent could not be deployed.The procedure was completed using another of the same device.There were no patient complications reported as a results 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: 24918302
• Report Number: 3005099803-2026-01434
• Device Sequence Number: 21447578
• Product Code: FGE
• UDI-Device Identifier: 08714729787112
• UDI-Public: (01)08714729787112(17)270507(10)37975451
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: M00534560
• Device Catalogue Number: M00534560
• Device Lot Number: 0037975451
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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