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

Model Number	M00572290
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
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 biliary tree to treat a bile duct stricture during the endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent was attempted to be advanced over the wire, but it would not pass, and the tip of catheter detached from the stent.The procedure was completed using another of same device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the reported healthcare facility is: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of tip detached.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21903935
• Report Number: 3005099803-2025-01736
• Device Sequence Number: 19848459
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: (01)08714729896913
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: M00572290
• Device Catalogue Number: M00572290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/24/2025
• 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