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

Model Number	M00572300
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on march 31, 2023 that an epic biliary stent was to be implanted in the hepatic duct and common bile duct to treat a cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedure performed on (b)(6) 2023.During the procedure, the stent was unable to deploy.Also, the delivery system was noted to be broken.The device was removed; however, device fragments were left unretrieved.The procedure was completed with another epic biliary stent.Note: a photo of the complaint device inside the patient was provided and it was observed that the epic biliary stent was partially deployed.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Patient code e2008 captures the reportable event of unretrieved device fragment.

• 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: 16795437
• Report Number: 3005099803-2023-02089
• Device Sequence Number: 20432527
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: 08714729896920
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: 01/08/2025
• Device Model Number: M00572300
• Device Catalogue Number: 7230
• Device Lot Number: 0030816752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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