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

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that an implanted advanix biliary stent was removed during an endoscopic retrograde cholangiopancreatography for stent removal procedure in the common bile duct, performed on (b)(6) 2023.During the procedure, when the physician attempted to pull the stent from an exalt scope, the stent got stuck in the working channel.The stent was successfully removed in this procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; stent break.Please see block h10 for full investigation details.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable investigation result of stent break.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent was split in two parts and was jammed on the detached section.No other problems with the device were noted.The reported event was confirmed.Based on the gathered information, the failure found could have been caused by operational factors such as the removal technique used to retrieve the stent from the scope.The working channel of the endoscope used has an inner diameter (id) of 4.2mm.A 10f advanix stent is approximately 3.3mm in diameter, and 6.6mm if folded over on itself, which exceeds the endoscope working channel id.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

• Brand Name: ADVANIX 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17768952
• MDR Text Key: 323692644
• Report Number: 3005099803-2023-04893
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/18/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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