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

Model Number	M00572330
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
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 common bile duct to treat a malignant hilar stricture during an endoscopic ultrasound (eus) endoscopic retrograde cholangiopancreatography procedure (ercp) with bilateral biliary stenting procedure performed on (b)(6), 2024.The patient's anatomy was tortuous and was dilated during stent placement.During the procedure, the first epic stent was successfully placed in the right duct.However, the second epic stent placed in the left duct was not able to cross the stricture as the catheter was kinked.The device was removed, and the stricture was dilated using hurricane balloon.The second epic stent was re-introduced and was able to cross the stricture.The physician then proceeded to deploy both stents, the epic stent in the right duct deployed successfully while the epic stent in the left duct did not even after complete rolling of the thumb wheel.The second epic stent then deployed in the scope when it was being removed, and it had to be removed using forceps.The procedure was finally completed with a plastic stent in the left duct.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: hospital address: (b)(6) hospital, (b)(6).Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Imdrf impact code f2301 captures the reportable event of the stent being removed using forceps.
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 malignant hilar stricture during an endoscopic ultrasound (eus) endoscopic retrograde cholangiopancreatography procedure (ercp) with bilateral biliary stenting performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated during stent placement.During the procedure, the first epic stent was successfully placed in the right duct.However, the second epic stent placed in the left duct was not able to cross the stricture as the catheter was kinked.The device was removed, and the stricture was dilated using hurricane balloon.The second epic stent was re-introduced and was able to cross the stricture.The physician then proceeded to deploy both stents, the epic stent in the right duct deployed successfully while the epic stent in the left duct did not even after complete rolling of the thumb wheel.The second epic stent then deployed in the scope when it was being removed, and it had to be removed using forceps.The procedure was finally completed with a plastic stent in the left duct.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's facility address is (b)(6) hospital, g & g towers, (b)(6); reported here as facility address exceeded character limit for designated field.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Imdrf impact code f2301 captures the reportable event of the stent being removed using forceps.Block h11: an epic biliary delivery system was received for analysis; the stent was not returned.Visual inspection found the inner sheath kinked at more than one location, and the outer sheath was separated.No other damage was observed on the delivery system.Product analysis confirmed the reported event of stent premature deployment, delivery system difficult to cross lesion and inner shaft/sheath kinked, as the stent was not returned and the delivery system was found kinked and detached.The investigation concluded that the reported events and additional observed damages were most likely due to procedural factors as lesion characteristics and the technique used by the physician (force applied).Furthermore, a labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The user reinserted the kinked device back into the patient before attempting to deploy the stent.The ifu states, "caution: attempting to place the epic biliary endoscopic stent system in patients with severe anatomical angulation may prevent the stent from deploying or cause damage to the device.Do not use a kinked delivery system." the physician did not follow the steps cited in the instruction for use (ifu); therefore, a review and analysis of all available information indicated that the most probable cause is failure to follow instructions.

• 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: 19505675
• Report Number: 3005099803-2024-02684
• Device Sequence Number: 19842690
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 11/14/2024
• Device Model Number: M00572330
• Device Catalogue Number: M00572330
• Device Lot Number: 0030539385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 68 KG