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

Model Number	M00572340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was used to treat an approximately 3cm malignant hilar stricture during a bilateral stenting procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed.The stent was fully covered by the outer sheath on the delivery system when it was removed from the patient.A plastic stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: photos of the complaint device were provided, and it was observed that the outer blue sheath was broken, and the inner sheath was kinked.This event has been deemed an mdr reportable event based on the investigation results which revealed that the inner sheath was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter's address is (b)(6); reported here as the address exceeded character limit for designated field.Block h6: imdrf a0501 captures the reportable investigation findings of inner sheath detachment of device or device component.Block h11: an epic biliary stent and delivery system were received for analysis.The stent was received fully constrained in the correct position on the delivery system.Visual inspection found that the inner and outer sheath were detached and kinked in several locations.Functional inspection related to stent deployment could not be performed due to the problems noted on the device.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported events of stent failure to deploy, sheath break, and inner sheath kinked.It is most likely that the patient's tortuous anatomy contributed to the difficulty in deploying the stent.Additionally, the inner and outer sheath were kinked due to the excessive force being applied when attempting to position the device.Moreover, the additional observed event of inner sheath detached was most likely due to the excessive force being applied when attempting to deploy the stent.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to patient condition.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• 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: 22137569
• Report Number: 3005099803-2025-02557
• Device Sequence Number: 17922708
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: (01)08714729896968(17)260122(10)33270781
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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: 01/22/2026
• Device Model Number: M00572340
• Device Catalogue Number: M00572340
• Device Lot Number: 0033270781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 60 KG