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

Model Number	M00572340
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the common bile duct to treat a 4cm cholangiocarcinoma 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 unable to deploy completely even after multiple attempts.The stent was partially covered by the outer sheath on the delivery system when it was removed from the patient.A non-boston scientific device was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the common bile duct to treat a 4cm cholangiocarcinoma 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 unable to deploy completely even after multiple attempts.The stent was partially covered by the outer sheath on the delivery system when it was removed from the patient.A non-boston scientific device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block b1 (adverse event or product problem) and d4 (catalog number and unique identifier udi number) have been corrected.Block g1 (mfr contact first name and last name, phone number, and email) has been updated.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an epic biliary stent and delivery system were received for analysis.The stent was received partially deployed on the delivery system.Visual inspection found no issues with the tip of the device, no kinks or damage to the outer sheath, and the handle rack had no issues or damage to the handle.The device was received with the rack extended on the device.Functional inspection found that the stent was unable to deploy as the thumb wheel would not turn any further.The handle was then opened with no damage found inside, the stainless-steel shaft was able to be extended, and the stent was able to be deployed.The stent was noted to be damaged.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported events of stent partially deployed.The stent was damaged most likely due to when the user was attempting to deploy the stent in the challenging patient's anatomy.The investigation concluded that the device encountered difficult patient anatomy could have contributed to the difficulty in deploying the stent during the procedure.Therefore, taking all available information into consideration, the selected most probable cause is adverse event related to patient condition.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 18032132
• Report Number: 3005099803-2023-05837
• Device Sequence Number: 7018068
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: (01)08714729896968(17)250108(10)30816756
• 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): 08/26/2025

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: M00572340
• Device Catalogue Number: M00572340
• Device Lot Number: 0030816756
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male
• Patient Race: Asian