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

Model Number	M00539220
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached/separated.Block h11: a flexima biliary stent was returned for analysis.A visual examination of the returned device revealed that the guide catheter was broken and kinked.Microscopic examination was performed, and it was observed that the push catheter suture hole was torn, and the suture from the push catheter suture hole was not returned with the device.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy and use of device issue user error.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were most likely the result of failure to follow the instructions for use ifu, resulting in improper deployment conditions and excessive procedural forces during attempted stent deployment.The investigation determined that the device was used in a manner inconsistent with the instructions for use.Specifically, the guidewire was not fully retracted into the delivery system prior to deployment and remained positioned within the bile duct during the attempted deployment.According to the ifu, failure to completely retract the guidewire prevents full stent deployment.Skipping this critical step most likely prevented successful deployment of the stent.The push catheter suture hole was observed torn.This damage may have occurred due to excessive force applied during attempted deployment, potentially influenced by physician technique and/or procedural tortuosity.The added pressure exerted on the suture at the torn suture hole likely caused the suture to become lodged and subsequently detach, preventing normal stent release.Additionally, there is a possibility that the same deployment force contributed to the guide catheter becoming bent, kinked, and ultimately separated, as observed during analysis.Therefore, a review and analysis of all available information indicated that the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat a stenosis of the upper segment of bile duct in the upper segment of bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation prior to the procedure, the stent was advanced across the stenosis segment and deployed, however, the inner core could not be separated.Another flexima biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the guide catheter was detached.Please see block h11 for full investigation details.

• Brand Name: FLEXIMA? 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: 24135757
• Report Number: 3005099803-2026-00271
• Device Sequence Number: 10394431
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: (01)08714729162537(17)270726(10)34518811
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K965147
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: M00539220
• Device Catalogue Number: M00539220
• Device Lot Number: 0034518811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 63 KG