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

Model Number	M00534360
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded double bend stent was used in the papilla of vater to treat stones during a stent placement procedure performed on (b)(6) 2025.During the procedure, when the stent was inserted, the guide catheter broke into two pieces.Subsequently, the broken guide catheter was removed together with the duodenoscope.The procedure was completed with another advanix biliary preloaded stent.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: an advanix biliary stent with naviflex delivery system was received for analysis.Visual and microscopic inspections found that the guide catheter was broken, and the stent suture hole and the push catheter suture hole were torn.The pull wire cap was detached and was not returned.No other problems were noted with the device.Product analysis confirmed the reported event of catheter guide break.The reported event of guide catheter broken was most likely due to the device being pulled with too much force, and the tortuosity of the procedure contributed to the difficulty in pulling the guide catheter.Furthermore, the push catheter torn suture and pullwire cap detachment could have occurred due to the pressure when trying to deploy the stent possibly due to the physician's technique or tortuosity of the procedure.It is most likely that the stent could not be deployed, and the push catheter suture hole was damaged by the pressure that the suture was adding to the suture hole.Since the push catheter suture hole was torn, the suture was most likely stuck in the suture hole and the stent could not be deployed.It is possible that the same force applied when trying to deploy the stent resulted in the stent suture hole and push catheter suture hole being torn, and the pull wire cap detachment.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the guidewire was inside the patient during the attempted deployment.However, the ifu states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was used in the papilla of vater to treat stones during a stent placement procedure performed on (b)(6) 2025.During the procedure, when the stent was inserted, the guide catheter broke into two pieces.Subsequently, the broken guide catheter was removed together with the duodenoscope.The procedure was completed with another advanix biliary stent with naviflex delivery system.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.

• Brand Name: ADVANIX BILIARY
• Common Device Name: 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21256500
• Report Number: 3005099803-2025-00195
• Device Sequence Number: 9053858
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: (01)08714729787457(17)250510(10)34061273
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2025
• Device Model Number: M00534360
• Device Catalogue Number: M00534360
• Device Lot Number: 0034061273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown