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

Model Number	M00572330
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation on january 25, 2023, that an epic biliary endoscopic stent was to be implanted in the mid-common bile duct to treat an approximately 3-5 cm hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with a biliary self-expanding metal stent (sems) implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the epic biliary stent was unable to deploy even after completely pulling back the handle and clicking the thumb wheel.The epic biliary stent was removed partially deployed on the delivery system, and the procedure was completed with another device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: the epic biliary endoscopic stent and delivery system were received for analysis.The stent was returned partially deployed by approximately 30 mm on the delivery system.Visual and tactile inspection identified the inner sheath was kinked at the distal tip bond.Functional examination revealed no problem with the release of the stent from the delivery system.No other issues were noted with the stent delivery system.Product analysis confirmed the reported event of stent partially deployed.The investigation concluded that partial stent deployment was not a new failure type and that the risk was anticipated.The patient's tortuous anatomy could have potentially contributed to the resistance encountered when attempting deployment of the stent, and the shaft kinking was most likely due to an interaction between the user and the device.However, the stent was fully deployed without issue during analysis suggesting that the event was not device related.Therefore, review and analysis of all available information indicated that 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.Block h11: block d4 (catalog number) has been corrected.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an epic biliary endoscopic stent was to be implanted in the mid-common bile duct to treat an approximately 3-5 cm hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with a biliary self-expanding metal stent (sems) implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the epic biliary stent was unable to deploy even after completely pulling back the handle and clicking the thumb wheel.The epic biliary stent was removed partially deployed on the delivery system, and the procedure was completed with another device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: 16358615
• Report Number: 3005099803-2023-00710
• Device Sequence Number: 6270349
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 12/13/2023
• Device Model Number: M00572330
• Device Catalogue Number: 7233
• Device Lot Number: 0028545650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 45 KG