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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during a procedure performed on an unknown date.During the procedure, the device was presenting a defect during use, making it impossible to use.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 guide catheter was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: date of event was approximated to august 01, 2025 as no specific event date was reported.Block e1: initial reporter address: (b)(6); reported here as it exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached.Block h11: a flexima biliary stent was returned for analysis.A visual examination of the returned device revealed that the guide catheter was detached and positioned outside of the push catheter.Additionally, the guide catheter exhibited stretching and kinking, and the suture hole on the push catheter was torn.No other damages were noted to the stent or the delivery system.Product analysis confirmed the reported event of device damaged defective.Taking all available information into consideration, the investigation concluded that the reported event and additional observed damages were likely the result of procedure related factors.The push catheter suture hole was found torn, which may have resulted from pressure experienced during stent deployment, potentially influenced by procedural tortuosity or deployment technique.Resistance encountered during deployment likely contributed to damage at the suture hole.The push catheter was also returned kinked, which would have made stent release difficult.Excessive force applied during attempts to deploy the stent may have caused the suture to become caught on the stent flap, preventing release.This same force may also have contributed to the guide catheter detaching during the procedure.Additionally, the guide catheter was returned kinked and stretched.This damage is consistent with the device being subjected to excessive pulling force, possibly due to anatomical tortuosity placing the guide catheter in a challenging position during manipulation or removal.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• 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: 24039857
• Report Number: 3005099803-2026-00160
• Device Sequence Number: 13388133
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)280415(10)36312284
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: M00539260
• Device Catalogue Number: M00539260
• Device Lot Number: 0036312284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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