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

Model Number	M00572260
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the investigation result of stent deformed.Block h11: an epic biliary stent and delivery system were returned for analysis.The stent was received fully deployed and expanded.Visual examination found the stent was noted to be kinked at one end.Multiple kinked were noted on the inner and outer sheath kinked.No other damage was noted to the stents and delivery system.Product analysis did not confirm the reported event of stent failure to deploy.The kinks noted to the delivery system were most likely due to an interaction between the user and the device during procedure.The damaged noted to the stent most likely occurred outside the patient.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu).The ifu states that, "the epic biliary endoscopic stent system is intended to treat patients with biliary strictures created by malignant neoplasms and is to be delivered endoscopically." the stent is not intended to be placed in the hilum.Therefore, a review and analysis of all available information indicated the most probable cause is cause traced to intentional off-label, unapproved, or contraindicated use.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted in hilum to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, there was difficulty operating the thumb wheel on the delivery system, resulting in the stent not deploying.The procedure was successfully completed with another epic biliary stent from a different lot.No patient complications were reported as a result of this event.Note: this complaint has been deemed mdr reportable based on the investigation findings which revealed the stent was deformed.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22523764
• Report Number: 3005099803-2025-03379
• Device Sequence Number: 20852655
• Product Code: FGE
• UDI-Device Identifier: 08714729896883
• UDI-Public: (01)08714729896883(17)260606(10)34180940
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 06/06/2026
• Device Model Number: M00572260
• Device Catalogue Number: M00572260
• Device Lot Number: 0034180940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown