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

Model Number	M00539290
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	03/19/2025
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 common bile duct to treat a stricture during a endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the flexima biliary stent was hard to deploy.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that 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 bliary stent was received for analysis.Visual examination of the returned device found the guide catheter was detached and kinked.Microscopic inspection was performed, and it was observed that the push catheter suture hole was torn.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy based on the condition in which the device was returned.Taking all available information into consideration, the investigation concluded that the reported event and additional observed damages were most likely procedural factors as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, the most probable cause of the reported event 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22510577
• Report Number: 3005099803-2025-03177
• Device Sequence Number: 13087313
• Product Code: FGE
• UDI-Device Identifier: 08714729162605
• UDI-Public: (01)08714729162605(17)270925(10)34928862
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: M00539290
• Device Catalogue Number: M00539290
• Device Lot Number: 0034928862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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 Sex: Unknown