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

Model Number	M00572290
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the bile duct to treat a malignant hilar tumor during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on an unknown date.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the epic stent was advanced over the guidewire.However, as the stent exited the scope, it was noted that it had partially deployed at the tip of the device before the deployment process had been initiated.The premature deployed stent was removed, and the procedure was completed using another device of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated based on the date the manufacturer became aware of the event, this information was not available as per account/customer.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.

• 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: 23610422
• Report Number: 3005099803-2025-06062
• Device Sequence Number: 21311722
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: (01)08714729896913(17)260416(10)33833913
• 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): 11/20/2025

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: 04/16/2026
• Device Model Number: M00572290
• Device Catalogue Number: M00572290
• Device Lot Number: 0033833913
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 04/16/2024
• 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