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

Model Number	M00539220
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter's first name is (b)(6); reported here as first name exceeded character limit for designated field.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
This report pertains to one of two flexima biliary devices used in the same patient.Refer to manufacturer report# 3005099803-2025-03892 for the associated device information.It was reported to boston scientific corporation that two flexima biliary stents were attempted to be implanted in the biliary tract to treat a biliary obstruction during an endoscopic retrograde cholangiopancreatography procedure (ercp) procedure performed on (b)(6) 2025.During the procedure, the first flexima biliary stent (subject of this report) did not completely deploy.The thread that holds it to the pusher did not release, requiring forceful traction, which led the device to rupture.A second flexima stent (subject of manufacturer report # 3005099803-2025-03892) was then used; however, the same problem occurred.The stents were removed, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block e1 (initial reporter email) was updated based on the additional information received on october 30, 2025.Block e1: initial reporter's first name is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
This report pertains to one of two flexima biliary devices used in the same patient.Refer to manufacturer report# 3005099803-2025-03891 and 3005099803-2025-03892 for the associated device information.It was reported to boston scientific corporation that two flexima biliary stents were attempted to be implanted in the biliary tract to treat a biliary obstruction during an endoscopic retrograde cholangiopancreatography procedure (ercp) procedure performed on (b)(6) 2025.During the procedure, the first flexima biliary stent (subject of this report) did not completely deploy.The thread that holds it to the pusher did not release, requiring forceful traction, which led the device to rupture.A second flexima stent (subject of manufacturer report # 3005099803-2025-03892) was then used; however, the same problem occurred.The stents were removed, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22728140
• Report Number: 3005099803-2025-03891
• Device Sequence Number: 18230842
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: (01)08714729162537(17)260626(10)31905251
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 06/26/2026
• Device Model Number: M00539220
• Device Catalogue Number: M00539220
• Device Lot Number: 0031905251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 06/27/2023
• 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 Sex: Unknown