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

Model Number M00534290

Device Problems Break (1069); Use of Device Problem (1670); Material Deformation (2976)

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

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the additional device to remove the broken guide catheter.

Event Description

It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was to be used in the common bile duct to treat a stricture secondary to cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, the guide catheter broke from the push catheter and was left in the common bile duct.The broken guide catheter was removed from the patient using graspers, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "pull back on the pull wire cap to adjust the length of the guide catheter in front of the stent, and engage the naviflex rx delivery system locking mechanism.Slide the stent barb cover so it is on the distal end of the blue push catheter near the stent." the physician did not follow the steps cited in the ifu.

• 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: 18998197
• MDR Text Key: 338877464
• Report Number: 3005099803-2024-01295
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: 08714729787389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101314
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00534290
• Device Catalogue Number: 3429
• Device Lot Number: 0031978948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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 Outcome(s): Required Intervention