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

Model Number	M00572340
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the left hepatic bile duct to treat a biliary stricture due to cholangiocarcinoma during a endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the yellow luer lock flushing attachment was not removed from the back of the epic device, and the guidewire did not come out of the epic stent.The stent was able to be fully deployed; however, the stent was deployed more distal to the right hepatic duct.The physician used an argon plasma coagulation apc to cut a portion of the stent that was placed in the duodenum, and a different stent was placed stent-in-stent to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the customer did not remove the yellow luer lock flushing attachment from the back of the epic biliary stent.However, the epic biliary endoscopic instructions for use state, "remove the flushing luer" the physician did not follow the steps cited in the instructions for use (ifu).
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.

• 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: 20262589
• Report Number: 3005099803-2024-04577
• Device Sequence Number: 12937757
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2025
• Device Model Number: M00572340
• Device Catalogue Number: 56705
• Device Lot Number: 0030907339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/19/2024
• Date Device Manufactured: 01/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown