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

Model Number	M00572300
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	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter address: (b)(6).Block h6: imdrf device code a15 captures the reportable event of partial stent deployment.
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 a hilar stricture metal stenting procedure performed on (b)(6) 2023.During the procedure, the stent could only be partially deployed using the thumbwheel method.The stent was attempted to be deployed using the pull-grip method, but it could not be deployed.The stent was removed from the patient partially deployed on the delivery system, and a different stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the initial reporter address is plot no mig 165 166, d no 1-113-20/1, sector 8, ushodaya junction.Block h6: imdrf device code a15 captures the reportable event of partial stent deployment.Block h10: the epic biliary stent and delivery system were received for analysis.Visual inspection found that the stent was partially deployed on the delivery system.A tactile and visual inspection found that the outer sheath had separated from the handle, and the inner sheath was severely kinked at more than one location.Also, the inner sheath was found to be buckled proximal to the distal tip.Additionally, no damages were found on the tip and handle of the device during the visual and tactile examinations.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of partial stent deployment.The investigation concluded that this event and the additional investigation findings of inner sheath kinking and sheath being detached were most likely due to factors that occurred during the procedure.It was most likely that the device may have encountered difficult patient anatomy as it was used to treat a hilar stricture (blockage or narrowing of the bile duct), which would have contributed to the difficulty in deploying the stent.The sheath kinking/buckling and outer sheath separation most probably occurred due to excessive force being applied to the device when attempting to deploy the stent.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.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 common bile duct to treat a malignant hilar stricture during a hilar stricture metal stenting procedure performed on (b)(6) 2023.During the procedure, the stent could only be partially deployed using the thumbwheel method.The stent was attempted to be deployed using the pull-grip method, but it could not be deployed.The stent was removed from the patient partially deployed on the delivery system, and a different stent was used to complete the procedure.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18076589
• Report Number: 3005099803-2023-05870
• Device Sequence Number: 18074880
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: 08714729896920
• 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): 04/08/2024

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: 11/19/2023
• Device Model Number: M00572300
• Device Catalogue Number: 56705
• Device Lot Number: 0028419642
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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