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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was used in the common bile duct to treat a malignant 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 first stent was successfully placed in the left hilar duct; however, the second stent could not be deployed and while pulling out the stent, the handle was broken.The stent was fully covered by the outer sheath when it was removed from the patient.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Note: 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 h6: imdrf device code a0501 captures the investigation findings of inner sheath detached.Block h11: an epic biliary stent and delivery system were received for analysis.The stent was received fully constrained and in a correct position on the delivery system.Visual inspection found the handle rack separated from the pull grip.The inner sheath located approximately 70mm distal to the handle rack was detached and kinked at more than one location.A functional inspection related to the stent deployment could not be performed due to the separation of the inner sheath and handle.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported events of stent failure to deploy and handle break.The investigation concluded that the inner sheath was kinked likely when the device was attempted to advance or position which could have then contributed to the stent being unable to deploy.The handle break and inner sheath detachment were likely due to excessive force being applied when the device was attempted to be withdrawn from the patient.It was reported that the stricture was malignant and the anatomy tight/tortuous, this encountered challenging patient anatomy may cause extrinsic compression or severe angulation of the bile duct.Therefore, a review and analysis of all available information indicated the most probable cause 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21105767
• Report Number: 3005099803-2024-06808
• Device Sequence Number: 18336557
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• 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): 01/08/2025

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: 01/02/2025
• Device Model Number: M00572340
• Device Catalogue Number: M00572340
• Device Lot Number: 0030782425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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