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

Model Number	M00539270
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Stretched (1601); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in the common bile duct for stones during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed.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.Note: a photo of the device was provided and it can be observed that the guide catheter was detached, there are some kinks and an accordion like part of the guide catheter which seemed to be stretched.In addition, the push catheter was broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf device code a0401 captures the reportable event of push catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in the common bile duct for stones during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed.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.Note: a photo of the device was provided and it can be observed that the guide catheter was detached, there are some kinks and an accordion like part of the guide catheter which seemed to be stretched.In addition, the push catheter was broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf device code a0401 captures the reportable event of push catheter break.Block h11: investigation results the flexima biliary stent was received for analysis.The customer provided a picture in which the guide catheter appears broken and stretched, and the push catheter appears broken.The device label information was also visible in the image.Upon inspection of the returned device, the guide catheter was found to be broken, stretched, buckled, and kinked.The push catheter was observed to be broken, with the suture hole torn.The suture did not return, as it had detached.No other problems with the device were noted.Product analysis confirmed the reported events of stent failure to deploy, catheter guide break, catheter guide kinked, catheter guide stretched and push catheter break.These issues could have occurred if the device experienced resistance or pressure during the attempted stent deployment, possibly due to the physician's technique or procedural tortuosity.It is most likely that the device was unable to deploy the stent as expected, causing pressure on the push catheter suture hole.This pressure may have resulted in the suture hole tearing.Once torn, the suture was likely unable to move freely within the suture hole, preventing proper stent deployment.There is also a possibility that the same force applied during deployment caused both the stent suture hole and the push catheter suture hole to tear, ultimately leading to suture detachment.Additionally, the push catheter was found to be broken.Procedural factors such as device handling and the amount of force applied during deployment may have contributed to the damage observed in the push catheter.The guide catheter was returned kinked, detached, stretched, and buckled.This damage most likely occurred as a result of excessive pulling force.Procedural tortuosity may have placed the device in a position where withdrawing the guide catheter required more force than typical, resulting in the observed damage.Therefore, the most probable root cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.

• 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: 24066566
• Report Number: 3005099803-2026-00199
• Device Sequence Number: 21403132
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: (01)08714729162582(17)260815(10)32231635
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 02/20/2026

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 Expiration Date: 08/15/2026
• Device Model Number: M00539270
• Device Catalogue Number: M00539270
• Device Lot Number: 0032231635
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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 Age: 61 YR
• Patient Sex: Female