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

Model Number	M00539260
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	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, the device could not be deployed, and the catheter guide was broken.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, the device could not be deployed, and the catheter guide was broken.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401captures the reportable event of catheter-guide break.Block h11: the flexima biliary stent was not returned for analysis; however, media analysis was performed on a video provided by the complainant where it can be observed that it was not possible to introduce a guidewire, and the guide catheter was observed kinked.Product analysis could not confirm the reported events of catheter guide break and stent failure to deploy; the product was not returned for analysis.Based on the information available and without proper evaluation of the device, it is unknown if the clinical observations were due to the technique used during the procedure, anatomical conditions or related to device malfunction.Therefore, due to the lack of evidence and without proper evaluation of the complaint device, cause not established is selected as the most probable root cause.

• 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: 23829802
• Report Number: 3005099803-2025-06753
• Device Sequence Number: 21149326
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)261203(10)32983202
• 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): 01/20/2026

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: 0032983202
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/20/2026
• Date Device Manufactured: 12/04/2023
• 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