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

Model Number	M00539300
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	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a common bile duct stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent had separated at the pigtail (proximal side) flap.Another flexima biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.
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 stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent had separated at the pigtail (proximal side) flap.Another flexima biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: a flexima biliary stent was returned for analysis.A visual examination of the returned device revealed that the push catheter was bent, the push catheter suture hole was torn, and the suture was detached and did not return with the device.Additionally, one of the stent barbs was found to be detached and was also not returned.Microscopic examination was performed, which confirmed the observed damage and showed no evidence of additional abnormalities.No other damages were noted to the stent or the delivery system.Product analysis confirmed the reported event of stent break, as well as related findings involving damage to the push catheter suture hole, suture detachment, and bending/kinking of the catheter push component.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely attributable to forces applied during the procedure, most probably influenced by procedural technique and/or anatomical tortuosity encountered during device deployment.The push catheter suture hole was found to be torn.This damage could have occurred if the device experienced undue pressure during attempted stent deployment.Bending of the push catheter may have impeded proper stent deployment and contributed to tearing of the suture hole.These factors could also lead to detachment of the stent barb and suture, or stent damage if excessive force was applied or if a suture became stuck during insertion.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• 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: 23686982
• Report Number: 3005099803-2025-06472
• Device Sequence Number: 20309385
• Product Code: FGE
• UDI-Device Identifier: 08714729162612
• UDI-Public: (01)08714729162612(17)270802(10)34560354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: M00539300
• Device Catalogue Number: M00539300
• Device Lot Number: 0034560354
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown