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

Model Number	M00534330
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920); Positioning Problem (3009); Poor Visibility (4072)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf impact code f2301 captures the additional device to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that a advanix stent with naviflex delivery system was to be implanted in the bile duct to treat choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the doctor faced difficulty passing the stent into the duct.The stent was eventually deployed based on the endoscopic marker, but it was not visualized in the bile duct, and it was not attached to the delivery system either.The physician passed forceps down the endoscope working channel, but the stent was not expelled.The stent was not found.The physician believed that the stent was lost within the duodenum and is confident it will be expelled naturally.Another of the same device was used and the procedure was completed.There were no patient complications as a result of this event.Note: it was reported that the guidewire was in the patient bile duct 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 cannot 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 a advanix stent with naviflex delivery system was to be implanted in the common bile duct to treat choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the doctor faced difficulty passing the stent into the duct.The stent was eventually deployed based on the endoscopic marker, but it was not visualized in the bile duct, and it was not attached to the delivery system either.The physician passed forceps down the endoscope working channel, but the stent was not expelled.The stent was not found.The physician believed that the stent was lost within the duodenum and is confident it will be expelled naturally.Another of the same device was used and the procedure was completed.There were no patient complications as a result of this event.Note: it was reported that the guidewire was in the patient bile duct 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 cannot be fully deployed.The physician did not follow the steps cited in the ifu.***additional information received on june 24, 2025*** note: it was 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." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block b5 has been updated with additional information.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf impact code f2301 captures the additional device to remove the stent.

• 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: 22284896
• Report Number: 3005099803-2025-02752
• Device Sequence Number: 15685891
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: (01)08714729787426
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00534330
• Device Catalogue Number: M00534330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown