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

Model Number	M00539270
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	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat drainage in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, the stent fell off while being unpacked.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: no.(b)(6).Address was reported here as the address exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: a flexima biliary stent was returned for analysis.A review of the photos provided by the complainant showed evidence of a stretched and kinked guide catheter, along with the device label information.Visual examination of the returned device confirmed that the guide catheter was stretched and kinked, while the stent itself appeared to be in good condition.No other damage was noted to the stent or the delivery system.Product analysis could not confirm the reported event of stent breakage.Based on all available information, the investigation concluded that the reported event and the observed damage were likely unrelated to a product defect.Furthermore, the reported event occurred during the procedure, and there is no objective evidence or descriptive details to substantiate it.However, the guide catheter was returned kinked and stretched, which most likely resulted from excessive force applied during device removal, possibly due to procedural tortuosity that made extraction difficult.Therefore, after reviewing and analyzing all available information, the most probable cause was determined to be no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat drainage in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, the stent fell off while being unpacked.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 23453158
• Report Number: 3005099803-2025-05772
• Device Sequence Number: 8188493
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: (01)08714729162582(17)270424(10)33891988
• 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): 12/31/2025

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: 0033891988
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 72 KG