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

Model Number M00572330

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an epic biliary stent was to be implanted in the hilar to treat a hilar block with malignancy during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, there was a resistance while advancing the stent but was eventually advanced into the patient's anatomy.The stent was attempted to be deployed; however, the stent could not be seen under fluoroscopy as the stent did not deploy.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed using a different device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.

• 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: 19084479
• MDR Text Key: 340578849
• Report Number: 3005099803-2024-01514
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00572330
• Device Catalogue Number: 56705
• Device Lot Number: 0030236226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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