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

Model Number	M00572340
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable investigation results which revealed that the epic biliary stent was received partially deployed on the delivery system.Block h10: an epic biliary stent and delivery system were returned for analysis.The stent was received partially deployed on the delivery system.Visual inspection did not find any kinks or visible problems with the sheath, the tip of the device, or the handle.During functional inspection, the stent was able to be fully deployed without any problems.No other problems with the stent and delivery system were noted.Product analysis did not confirm the reported event of stent failure to deploy as the stent was able to be deployed without any problems during functional examination.It is most likely that the device encountered difficult patient's anatomy such as extrinsic compression or severe angulation of the bile duct despite the stricture being pre-dilated and could have contributed to the resistance encountered during stent deployment.There is no indication of what the customer reported because the stent was able to be fully deployed during analysis.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was used to treat a malignant stricture in the right and left hilar ducts during a bilateral stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the first epic biliary stent was deployed; however, the second stent was unable to be deployed.The stent was fully covered by the outer sheath when it was removed from the patient.A plastic stent was placed, and the procedure was completed.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 stent was returned partially deployed on the delivery system.Please see block h10 for full investigation details.

• 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: 18379480
• Report Number: 3005099803-2023-06808
• Device Sequence Number: 20727845
• 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): 12/21/2023

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: 08/16/2024
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0029966679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: Male