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

Model Number	M00539250
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During procedure, difficulties were encountered during the deployment phase.Immediately following the final positioning of the stent, the components of the device separated and fell apart.The procedure was completed using the original device.There was no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: the flexima biliary delivery system was not received for analysis.Therefore, a technical analysis could not be performed.Based on the information available and without proper evaluation of the device, it is unknown if the reported events were due to the physician's technique during the procedure, or whether it was related to a device malfunction.Product analysis could not confirm the reported event of guide catheter break, as the delivery system was not returned for analysis.The investigation concluded that the reported event and the additional observed damages in the delivery system were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.Therefore, taking all available information into consideration, the most probable cause is unable to exclude device problem.A labeling review was performed, and from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/product label.

• 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: 24500605
• Report Number: 3005099803-2026-00812
• Device Sequence Number: 18631961
• Product Code: FGE
• UDI-Device Identifier: 08714729162568
• UDI-Public: (01)08714729162568(17)281202(10)38096881
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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,Followup
• Report Date (Section B): 05/21/2026

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: M00539250
• Device Catalogue Number: M00539250
• Device Lot Number: 0038096881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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