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

Model Number	M00572260
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address 2:(b)(6).Block h6: imdrf device code a0203 captures the reportable event of stent size incorrect.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was implanted in the upper part of the common bile duct to treat an obstructive jaundice due to klatskin tumor type i during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous due to the klatskin tumor and was not dilated prior to stent placement.During the procedure, the stent was deployed; however, it was noted that the stent was wider and shorter than the labeled length.The stent remains implanted since it adequately covered the stenosis, but difficulty in removing the delivery system was also encountered.The procedure was completed using the original stent.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 2: (b)(6) reported here as it exceeded character limit for the designated field.Block h6: imdrf device code a0203 captures the reportable event of stent size incorrect.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Block h11: an epic biliary endoscopic delivery system was returned for analysis as it remained implanted; the stent was not returned.Visual and tactile examination revealed the inner sheath fractured approximately 3 mm from the distal marker band.The tip section of the inner sheath was missing and not returned.Additionally, the pull grip section and outer sheath were detached from the handle.No other problems were observed with the delivery system.Product analysis did not confirm the reported event of stent size incorrect, as no device damage was observed and the stent functioned as intended.The stent is designed to foreshorten and widen upon deployment, with final length varying based on lesion compression.Per instructions for use, the stent of this device will foreshortening approximately 3%, and the user did not specify the perceived stent length.Additionally, vessel tortuosity likely contributed to the reported event of delivery system difficult to remove, which may have resulted in inner/outer sheath breakage due to excessive force applied during device removal.Taking all available information into consideration, the investigation concluded that the most probable cause is no problem detected.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 implanted in the upper part of the common bile duct to treat an obstructive jaundice due to klatskin tumor type i during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous due to the klatskin tumor and was not dilated prior to stent placement.During the procedure, the stent was deployed; however, it was noted that the stent was wider and shorter than the labeled length.The stent remains implanted since it adequately covered the stenosis, but difficulty in removing the delivery system was also encountered.The procedure was completed using the original stent.No patient complications were 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: 21815676
• Report Number: 3005099803-2025-01463
• Device Sequence Number: 21041475
• Product Code: FGE
• UDI-Device Identifier: 08714729896883
• UDI-Public: (01)08714729896883(17)260606(10)34180943
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/30/2025

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: 0034180943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 12/30/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male