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

Model Number	M00539220
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent barb torn.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat a common bile duct stone in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with endoscopic sphincterotomy (est) procedure performed on (b)(6) 2025.During preparation for the procedure, the barb of the stent fractured during unpacking, rendering the device unusable.The procedure was successfully completed using another flexima biliary stent.There were no patient complications reported as a result of this event.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 to be implanted to treat a common bile duct stone in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with endoscopic sphincterotomy (est) procedure performed on (b)(6) 2025.During preparation for the procedure, the barb of the stent fractured during unpacking, rendering the device unusable.The procedure was successfully completed using another flexima biliary stent.There were no patient complications reported 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 h6: imdrf device code a0414 captures the reportable event of stent barb torn.Block h11: the flexima biliary stent was not returned for evaluation; therefore, a physical product analysis could not be performed.However, the documentation provided by the customer included photographs of the stent.A media analysis was conducted based on these images.The photographs revealed that a portion of the stent, including one of the stent barbs, appeared to be detached.Media analysis cannot confirm the reported event of stent barb torn material.The customer provided some pictures where it can be observed that part of the stent and one of the stent barbs were detached; however, without proper evaluation of the device it remains unknown the most probable causes that contributed to the event.There is not enough evidence to determine if the reported event was related to the physician's technique during the procedure, due to the anatomical conditions or related to a device malfunction.Taking all available information into consideration, the most probable cause of the reported event is cause not established.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent barb torn.Block h11: a flexima biliary stent was returned for analysis.A visual examination of the returned device revealed that one stent barb was detached.The documentation provided by the customer included photographs of the stent.A media analysis was conducted based on these images.The photographs revealed that a portion of the stent, including one of the stent barbs, appeared to be detached.No other damages observed on the stent.Product analysis confirmed the reported event of stent barb detachment.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely due to procedural factors such as device handling, physician technique, or force applied while introducing the stent into the scope likely contributed to the damage, as the stent barb was fractured during deployment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat a common bile duct stone in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with endoscopic sphincterotomy (est) procedure performed on (b)(6) 2025.During preparation for the procedure, the barb of the stent fractured during unpacking, rendering the device unusable.The procedure was successfully completed using another flexima biliary stent.There were no patient complications reported 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: 22974314
• Report Number: 3005099803-2025-04526
• Device Sequence Number: 9540636
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: (01)08714729162537(17)271009(10)35028754
• 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,Followup
• Report Date (Section B): 12/15/2025

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: M00539220
• Device Catalogue Number: M00539220
• Device Lot Number: 0035028754
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 11/17/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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: 40 KG