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

Model Number	M00572300
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat malignant biliary stricture during a procedure performed on (b)(6) 2025.During the procedure, the proximal part of the stent was not opened.It was noted that the stent was only 50% deployed and it was closed and removed.The procedure was completed with another stent of a different model.There were no patient complications reported due to this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Additional Manufacturer Narrative
Block b5 has been corrected.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat malignant biliary stricture during a procedure performed on (b)(6) 2025.The patient's anatomy was tortuous (tight) and it was dilated prior to stent placement.During the procedure, the proximal part of the stent was not opened.It was noted that the stent was only 50% deployed and it was closed and removed.The procedure was completed with another stent of a different model.There were no patient complications reported due to 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 ; 9145716918
• MDR Report Key: 24180801
• Report Number: 3005099803-2026-00291
• Device Sequence Number: 9979421
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: (01)08714729896920(17)260612(10)34223578
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171809
• 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,Followup
• Report Date (Section B): 02/05/2026

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 Expiration Date: 06/12/2026
• Device Model Number: M00572300
• Device Catalogue Number: M00572300
• Device Lot Number: 0034223578
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 06/12/2024
• 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