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

Model Number	M00539200
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted to treat biliary stenosis in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on april 03, 2026.During the procedure, when the stent pusher was pulled, the connecting wire fractured and the stent could not be deployed.Further information received confirmed the damage was not due to a suture break but rather at the connection point between the delivery system and the stent structure.Another flexima biliary preloaded 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: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the instructions for use (ifu): "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the user did not follow the ifu.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: the second affiliated hospital of shandong university of traditional chinese medicine; reported here as it exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.

• 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: 25361657
• Report Number: 3005099803-2026-02254
• Device Sequence Number: 10653621
• Product Code: FGE
• UDI-Device Identifier: 08714729337362
• UDI-Public: (01)08714729337362(17)280519(10)36567024
• 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): 06/23/2026

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: M00539200
• Device Catalogue Number: M00539200
• Device Lot Number: 0036567024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/23/2026
• Date Device Manufactured: 05/20/2025
• 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: Female
• Patient Weight: 57 KG