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

Model Number	M00539330
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 during an endoscopic biliary drainage (ebd) procedure performed on (b)(6) 2025.During the procedure, the connector at the proximal part of the inner sheath became disconnected.The broken guide catheter remained within the push catheter, allowing the delivery system to be removed in one piece.The procedure was completed using the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
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 during an endoscopic biliary drainage (ebd) procedure performed on (b)(6) 2025.During the procedure, the connector at the proximal part of the inner sheath became disconnected.The broken guide catheter remained within the push catheter, allowing the delivery system to be removed in one piece.The procedure was completed using the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a flexima biliary stent and delivery system were received for analysis.Visual and microscopic inspection found the guide catheter was detached; and the push catheter suture hole torn.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of catheter guide break.The investigation concluded that the reported event and additional observed damage of push catheter suture hole torn were most likely due to procedural factors 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 indicated the most probable cause of the events 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: 22436718
• Report Number: 3005099803-2025-03135
• Device Sequence Number: 16931777
• Product Code: FGE
• UDI-Device Identifier: 08714729162643
• UDI-Public: (01)08714729162643(17)270123(10)33280585
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/15/2025

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: M00539330
• Device Catalogue Number: M00539330
• Device Lot Number: 0033280585
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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