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

Model Number M00572260

Device Problems Premature Activation (1484); Use of Device Problem (1670)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a150103 captures the reportable event of stent premature deployment.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat a cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent was unable to deploy after approximately 12 clicks on the thumb wheel.While removing the delivery catheter, the stent popped out, and a part of the stent was prematurely deployed in the common bile duct and the other part was deployed in the scope.The stent was removed from the patient together with the scope, and the procedure was completed with plastic stents.There were no patient complications reported as a result of this event.

• 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: 16342084
• MDR Text Key: 309259204
• Report Number: 3005099803-2023-00511
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2023

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
• Device Operator: Health Professional
• Device Model Number: M00572260
• Device Catalogue Number: 7226
• Device Lot Number: 0029797669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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