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

Model Number	M00572280
Medical Device Problem Codes	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	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable investigation finding of stent partially deployed.Block h11: an epic biliary stent and its delivery system was received for analysis.Visual inspection noticed the stent was returned partially deployed on the delivery system, that the safety lock was not present, and that the sheath was kinked.Functional inspection was performed.A 0.035 guidewire was advanced and successfully loaded onto the device without any problems.No other issues were noted during analysis.Product analysis did not confirm the reported event of device difficult to advance guidewire, during functional inspection a guidewire was successfully loaded onto the device.The investigation concluded that the observed event of stent partially deployed most probably occurred due to the safety lock detaching from the device due to handling during preparation for the procedure.The stent cannot be deployed with the safety lock in place on the device.Premature removal of the safety lock would have led to accidental partial deployment of the stent.The additional observed event of sheath kinked was most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the common bile duct to treat a malignancy during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the guidewire would not backload in the epic biliary device.Another device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the stent was partially deployed.

• 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: 23536413
• Report Number: 3005099803-2025-05954
• Device Sequence Number: 10202550
• Product Code: FGE
• UDI-Device Identifier: 08714729896906
• UDI-Public: (01)08714729896906(17)270108(10)35579728
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/12/2025

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 Model Number: M00572280
• Device Catalogue Number: M00572280
• Device Lot Number: 0035579728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 73 KG