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

Model Number	M00534280
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); 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	02/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the biliary duct to treat gallbladder stones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the advanix naviflex delivery system snapped and broke, and the stent was unable to be deployed.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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the biliary duct to treat gallbladder stones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the advanix naviflex delivery system snapped and broke, and the stent was unable to be deployed.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 also reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion.".
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: an advanix naviflex biliary stent was received for analysis; only the guide catheter and stent were returned.Visual examination of the returned device found the guide catheter was detached and the stent suture hole was torn.Media inspection was performed, and it was observed that the guide catheter was detached, and the stent was undeployed.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy and guide catheter break.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to the tortuosity of the procedure, and the technique used by the physician when trying to deploy the stent, limited the performance of the device and contributed to the reported event and observed problems.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the guidewire was inside the patient during attempted deployment as the ifu states: "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." furthermore, the complainant reported that the barb flap was not used to insert the device through the biopsy cap as the ifu states: "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the physician did not follow the steps cited in the ifu.Therefore, a review and analysis of all available information indicated that the most probable cause is failure to follow instructions.

• 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: 21566916
• Report Number: 3005099803-2025-00911
• Device Sequence Number: 18457121
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: 08714729787372
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K203162
• 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): 06/11/2025

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: 09/17/2026
• Device Model Number: M00534280
• Device Catalogue Number: M00534280
• Device Lot Number: 0034998743
• 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: 02/16/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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