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

Model Number	M00539270
Medical Device Problem Codes	Positioning Failure (1158); Nonstandard Device (1420); 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	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).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 detached, buckled, and kinked.In addition, the push catheter suture hole was observed to be torn, and the suture did not return.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy, device damage/defect, and user related device use error.The device was unable to deploy the stent as intended, resulting in damage to the push catheter suture hole due to pressure from the suture.The torn suture hole likely caused the suture to become trapped or detached, preventing proper stent release.The guide catheter was detached, kinked, stretched, or buckled.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely caused by procedure related factors, including excessive force during deployment, potentially influenced by physician technique or anatomical tortuosity.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, the device appears to have been used in a manner inconsistent with the labeled instructions for use.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion; however, it was reported that the barb flap cover was not used to insert the device through the biopsy cap.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was intended to be implanted to treat bile duct stones in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed normally, and the inner core rolled up easily when manipulated with the guidewire.Another flexima biliary stent was used to successfully 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 detached/separated.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: 24500161
• Report Number: 3005099803-2026-00803
• Device Sequence Number: 10115323
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: (01)08714729162582(17)280423(10)36366298
• 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
• Report Date (Section B): 03/03/2026

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: M00539270
• Device Catalogue Number: M00539270
• Device Lot Number: 0036366298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 70 KG