MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Epic? Biliary; catheter, biliary, diagnostic

Model Number	M00572340
Medical Device Problem Codes	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	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
This report pertains to one of two epic biliary stents used during the same procedure.Refer to manufacturer report# 3005099803-2025-05832 and 3005099803-2025-05833 for the associated device information.It was reported to boston scientific corporation that two (2) epic biliary stents were to be implanted in the right and left hepatic ducts to treat a malignant cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography procedure (ercp) with bilateral stenting procedure performed on october 14, 2025.The patient's anatomy was not tortuous and was dilated prior to stent placement.During a bilateral stenting procedure, the first epic stent (subject of manufacturer report# 3005099803-2025-05832) did not open up, and the second epic stent (subject of this report) did not open up as well.The stents were removed partially deployed on the delivery system, and the procedure was completed using a different device.There were no patient complications reported as a result of this event.

• Brand Name: Epic? 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; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 23477891
• Report Number: 3005099803-2025-05833
• Device Sequence Number: 10227769
• Product Code: FGE
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/10/2026

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: M00572340
• Device Catalogue Number: M00572340
• Device Lot Number: 0035579802
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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