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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); 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	05/14/2025
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 to the biliary tract to treat a multiple biliary calculi during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the inner sheath core could not be pulled out and it was fractured.It was noted that the biliary duct was narrow.The procedure was completed using another of the same device there was no patient complications reported as a result of this event and the condition of the patient was reported to be stable.Note: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.".
Additional Manufacturer Narrative
Block e1: initial reporter address:(b)(6).Block h6: imdrf device code a0401 captures the reportable event of catheter guide - break.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6) block h6: imdrf device code a0401 captures the reportable event of catheter guide - break.Block h11: a flexima biliary stent was received for analysis.Visual examination of the returned device found the guide catheter kinked and unraveled.Additionally, the push catheter suture hole was torn.Also, the stent was still attached to the push catheter suture hole.Product analysis did not confirm the reported event of guide catheter break as there was no breakage on the guide catheter.The guide catheter was returned kinked and unraveled.The damages on the guide catheter may be related to user manipulation, some technique applied during procedure and/or extra force/tension to the device could have contributed to these issues, as it may have caused the push catheter suture hole to become torn.Therefore, a review and analysis of all available information indicated the most probable cause of the reported events is no problem detected a labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu.The complainant reported that guidewire was in the patient during the attempted deployment.The ifu states that if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to the biliary tract to treat a multiple biliary calculi during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the inner sheath core could not be pulled out and it was fractured.It was noted that the biliary duct was narrow.The procedure was completed using another of the same device there was no patient complications reported as a result of this event and the condition of the patient was reported to be stable.Note: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.".

• 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: 22185037
• Report Number: 3005099803-2025-02686
• Device Sequence Number: 12934200
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)270821(10)34683155
• 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,Followup
• Report Date (Section B): 08/12/2025

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: M00539260
• Device Catalogue Number: M00539260
• Device Lot Number: 0034683155
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 58 KG