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 07/13/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that an advanix biliary stent was to be removed during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2023.During the procedure, when the stent was attempted to be pulled through the endoscope, it got stuck.It was pushed out with a biopsy forceps and was pulled out with a snare.The procedure was completed successfully with another endoscope and there was no information if a new stent was implanted.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 findings 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 were jammed on the detached sections.No other problems with the device were noted.The reported event of device entrapment of device or device component was confirmed.Based on the gathered information, the failure 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 a working channel inner diameter of 4.2 mm and the 10f advanix stent was approximately 3.3mm in diameter, and 6.6mm if folded over on itself, which exceeds the endoscope working channel inner diameter; this could be the root cause of the device entrapment.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; 300 boston scientific way, MA 01752 ; 5086834015
• MDR Report Key: 17872515
• MDR Text Key: 324939354
• Report Number: 3005099803-2023-05287
• 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: 10/04/2023

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: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/04/2023
• 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