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

Model Number	M00572300
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the left hepatic duct to treat a malignant tumor secondary to cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, after the stent was deployed, the fluoro imaging was inspected and there appeared to be a possible foreign body from the stent system left in the patient.The delivery catheter was inspected after removal and it looked like everything was on the system that should be.The procedure was completed, and the stent remains implanted inside the patient.There were no patient complications reported as a result of this event.Note: it was reported that the imaging showed no foreign body inside the patient, and there were no visible damages noted to the device delivery system when it was inspected outside of the patient after removal; however, there was no indication that the physician was rescinding the complaint.Therefore, this complaint will be reported for foreign material present in the device.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of a foreign material present in the device.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of a foreign material present in the device.Block h10: the epic biliary stent and delivery system were received for analysis.Visual analysis found that the stent was deployed from the delivery system and no damages were noted on the tip and handle of the device.The tactile and visual inspection found that the inner sheath was stretched and severely kinked; however, there were no signs of missing or fractured material or components.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported event of foreign material present in the device because visual and tactile inspections showed no signs of missing or fractured material or components.The investigation concluded that there was no evidence of manufacturing problems or design problems that could have caused the complaint.It was possible that the inner sheath kinks may have resulted when the user attempted to advance or cross the target lesion and the stretching to the inner sheath may have occurred when the user may have applied excessive force to the device when attempting to remove the device from the challenging anatomy as the patient had a malignant tumor.It was further reported that the imaging showed no foreign body inside the patient and the investigator did not see or find any foreign matter on the device.Therefore, taking all available information into consideration, the overall root cause of the reported event is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the left hepatic duct to treat a malignant tumor secondary to cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2024.During the procedure, after the stent was deployed, the fluoro imaging was inspected and there appeared to be a possible foreign body from the stent system left in the patient.The delivery catheter was inspected after removal and it looked like everything was on the system that should be.The procedure was completed, and the stent remains implanted inside the patient.There were no patient complications reported as a result of this event.Note: it was reported that the imaging showed no foreign body inside the patient, and there were no visible damages noted to the device delivery system when it was inspected outside of the patient after removal; however, there was no indication that the physician was rescinding the complaint.Therefore, this complaint will be reported for foreign material present in the device.

• 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: 19050226
• Report Number: 3005099803-2024-01459
• Device Sequence Number: 8565901
• 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,Followup
• Report Date (Section B): 05/14/2024

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: 01/02/2025
• Device Model Number: M00572300
• Device Catalogue Number: 56705
• Device Lot Number: 0030782420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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