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

Model Number	M00572330
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
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 hilar to treat a hilar block with malignancy during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, there was a resistance while advancing the stent but was eventually advanced into the patient's anatomy.The stent was attempted to be deployed; however, the stent could not be seen under fluoroscopy as the stent did not deploy.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed using a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an epic biliary endoscopic was received for analysis.Visual examination of the returned device found the stent was partially deployed.The stent and inner sheath were noted to be kinked approximately 44 mm proximal from the distal tip.No other problems were noted to the stent and delivery system.The observed events of inner sheath kinked and stent damaged were most likely a result of interaction between the user and the device.Additionally, the reported patient anatomy and lesion characteristics may have contributed to the difficulty experienced when attempting to cross the lesion, leading to partial deployment of the stent.Therefore, the most probable cause of the reported event is an adverse event related to the procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the hilar to treat a hilar block with malignancy during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, there was a resistance while advancing the stent but was eventually advanced into the patient's anatomy.The stent was attempted to be deployed; however, the stent could not be seen under fluoroscopy as the stent did not deploy.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed using a different device.There were no patient complications reported as a result of 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: 19084479
• Report Number: 3005099803-2024-01514
• Device Sequence Number: 7621122
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• 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): 12/29/2025

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: 09/27/2024
• Device Model Number: M00572330
• Device Catalogue Number: M00572330
• Device Lot Number: 0030236226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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