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

Model Number	M00539240
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the investigation finding of guide catheter break.Block h11: a flexima biliary stent with its delivery system was received for analysis.Visual inspection showed that the guidewire was inside the guide catheter.The guide catheter was returned kinked, stretched, buckled, and it was detached from the push catheter.Additionally, the push catheter was buckled, and the push catheter suture hole was torn.Product analysis confirmed the reported event of stent failure to deploy.The investigation concluded that the torn push catheter suture hole may have occurred due to pressure applied during attempted stent deployment, potentially related to physician technique or procedural tortuosity.It is most likely that resistance encountered during deployment prevented the stent from deploying as intended, resulting in increased force being applied and subsequent damage to the push catheter suture hole.Additionally, the force applied during deployment may have contributed to the detachment of the guide catheter.The procedural conditions present at the time of deployment may also have caused the guide catheter to buckle, stretch, or kink, which could have further impeded stent deployment.These same conditions likely caused the push catheter to buckle in an accordion-like manner.Based on all available information, the most probable cause of the event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted for drainage (moderate stenosis) in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, it was reported that the stent could not be deployed when placing the stent for drainage.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event and the patient condition following procedure was stable.Note: this event has been deemed a reportable event based on the investigation finding of catheter guide detached or separated.Please see block h11 for full investigation details.

• 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: 24025545
• Report Number: 3005099803-2026-00142
• Device Sequence Number: 8952965
• Product Code: FGE
• UDI-Device Identifier: 08714729162551
• UDI-Public: (01)08714729162551(17)270618(10)34268103
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: M00539240
• Device Catalogue Number: M00539240
• Device Lot Number: 0034268103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 60 KG