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

Model Number	M00572340
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an epic biliary stent was to be implanted in the pancreas to treat gastric outlet obstruction during an esophagogastroduodenoscopy (egd) with fluoroscopy procedure performed on (b)(6), 2023.During the procedure, the stent was attempted to be deployed; however, the stent fully deployed inside the scope.No additional stent was implanted.There were no patient complications as a result of this event.Note: it was reported that the stent was intended to be placed to treat a gastric outlet obstruction (goo).However, per the epic biliary endoscopic stent system instructions for use, the stent is intended to treat patients with biliary strictures created by malignant neoplasms and is to be delivered endoscopically.The device is not indicated to be placed to treat a gastric outlet obstruction (goo).
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: blocks b5 has been corrected.
Event or Problem Description
It was reported to boston scientific corporation on june 29, 2023, that an epic biliary stent was to be implanted to treat gastric outlet obstruction during an esophagogastroduodenoscopy (egd) with fluoroscopy procedure performed on (b)(6) 2023.During the procedure, the stent was attempted to be deployed; however, the stent fully deployed inside the scope.No additional stent was implanted.There were no patient complications as a result of this event.Note: it was reported that the stent was intended to be placed to treat a gastric outlet obstruction (goo).However, per the epic biliary endoscopic stent system instructions for use, the stent is intended to treat patients with biliary strictures created by malignant neoplasms and is to be delivered endoscopically.The device is not indicated to be placed to treat a gastric outlet obstruction (goo).

• 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: 17338941
• Report Number: 3005099803-2023-03862
• Device Sequence Number: 7361789
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 09/27/2024
• Device Model Number: M00572340
• Device Catalogue Number: 56705
• Device Lot Number: 0030236227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: Unknown