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

Model Number	M00572340
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f23 captures the patient's referral to interventional radiology for a percutaneous transhepatic biliary drainage (ptbd) procedure.Imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was implanted in the common bile duct to treat an approximately 4cm malignant stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was advanced and deployed; however, the stent was unable to fully expand.A hurricane ballon was used to fully expand the stent but it was unable to pass through the stent.Subsequently, the patient was referred to interventional radiology for a percutaneous transhepatic biliary drainage (ptbd) procedure.The stent remained implanted and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4 (catalog number) has been corrected.Block h6: imdrf impact code f23 captures the patient's referral to interventional radiology for a percutaneous transhepatic biliary drainage (ptbd) procedure.Imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was implanted in the common bile duct to treat an approximately 4cm malignant stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was advanced and deployed; however, the stent was unable to fully expand.A hurricane ballon was used to fully expand the stent but it was unable to pass through the stent.Subsequently, the patient was referred to interventional radiology for a percutaneous transhepatic biliary drainage (ptbd) procedure.The stent remained implanted and the procedure was completed.There were no patient complications reported as a result of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 18544117
• Report Number: 3005099803-2023-07170
• Device Sequence Number: 18123556
• 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
• Device Implanted Year: 2023
• 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): 04/24/2026

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: 01/23/2025
• Device Model Number: M00572340
• Device Catalogue Number: M00572340
• Device Lot Number: 0030915844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: Asian