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

Model Number	M00539270
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the bile duct to treat gallstones during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2025.During the procedure, the flexima stent could not be deployed successfully.The procedure was completed using another flexima biliary stent.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the physician did not follow the steps cited in the ifu.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the guide catheter was detached.Please see block h11 for the full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter break.Block h11: a flexima biliary stent and delivery system was received for analysis.Visual examination of the returned device found the guide catheter kinked, stretched, buckled accordioned, and detached.The push catheter suture hole was found torn.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the barb flap was not used during the device insertion through the biopsy cap and the ifu states "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the investigation concluded that because the ifu was not followed, this was most likely the reason why the stent wasn't able to be deployed, and the additional observed damages on the delivery system were likely due to excessive force applied when it was felt that the stent wasn't deploying or also due to complications that could have appeared during the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause of the reported event is failure to follow instructions.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21561532
• Report Number: 3005099803-2025-00797
• Device Sequence Number: 4374066
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• 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
• Report Date (Section B): 03/10/2025

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 Expiration Date: 06/06/2026
• Device Model Number: M00539270
• Device Catalogue Number: M00539270
• Device Lot Number: 0031769513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 53 KG