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

Model Number	M00539220
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1 (initial reporter facility name) the second affiliated (b)(6) - reported here as it exceeded the maximum character limit of the designated field.Block h6: imdrf device code a0401 captures the reportable investigation findings of guide catheter detachment.Block h11: a flexima biliary preloaded stent was returned for analysis.Visual inspection revealed that the guide catheter was kinked and detached, the push catheter was found buckled accordion, and the push catheter suture hole was torn.Additionally, the suture did not deploy the stent.No other damage was found on the device.Product analysis confirmed the reported event of suture deployment issue.The investigation concluded that the reported event and additional observed damages were most likely procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, a review and analysis of all available information indicates the most probable cause of the events 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 in the common bile duct to treat cbd stones during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, an integrated biliary stent was introduced via duodenoscope; however, the connecting rope failed to disconnect, preventing successful deployment.The procedure was completed with another stent of a different model.There were no patient complications as a result this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the guide catheter was detached.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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22502311
• Report Number: 3005099803-2025-03341
• Device Sequence Number: 7001114
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: (01)08714729162537(17)250511(10)29389392
• 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): 07/14/2025

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: 05/11/2025
• Device Model Number: M00539220
• Device Catalogue Number: M00539220
• Device Lot Number: 0029389392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 05/12/2022
• 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