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

Model Number M00572340

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted in the hilar region of the common bile duct to treat a 5cm malignant stricture secondary to cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedure performed on (b)(6) 2023.The patient's anatomy was tight and tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed despite repeatedly using the thumbwheel and pull-grip deployment methods.The stent was covered by the outer sheath when removed from the patient, but it automatically opened.The procedure was completed with a plastic stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation finding which revealed the stent was partially deployed.Please see block h10 for the full investigation details.

Manufacturer Narrative

Block e1: initial reporter's phone number: (b)(6).Block h6: imdrf device code a15 captures the reportable event and product investigation findings of stent partial deployment.Block h10: the epic biliary stent and delivery system were received for analysis.Visual inspection found the stent was returned partially deployed on the delivery system.The outer sheath and inner sheath were kinked at more than one location, and the handle was not damaged at all.Visual and tactile inspection found no damage to the tip of the device.Functional analysis related to the deployment of the stent found that the stent was deployed without any problems.No other damages were noted with the stent or the delivery system.The investigation concluded that the reported event of stent failure to deploy was most likely due to anatomical factors encountered during the procedure.The device may have encountered difficult patient anatomy such as extrinsic compression or severe angulation of the bile duct which could potentially have contributed to the resistance encountered when attempting to deploy the stent.However, product analysis could not confirm this event as the stent was able to be deployed without problems during functional examination.The kink noted on the inner and outer sheath most likely occurred due to an unintended interaction between the user and the device, but at what stage of the procedure it occurred (during procedure/handling post procedure) cannot be established.Therefore, a review and analysis of all available information indicated that the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• Brand Name: EPIC BILIARY
• Type of Device: 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: 18383972
• MDR Text Key: 331496394
• Report Number: 3005099803-2023-06840
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K171809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0029961878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Race: Asian