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

Model Number	M00532290
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	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that an advanix biliary stent was used in the hepatic duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, a 10fr x 10cm double pigtail stent was properly loaded onto the advanix 10fr delivery system and positioned over the guidewire.Upon deployment, the radiopaque marker on the inner catheter of the delivery system remained within the hepatic duct even after the green deployment indicator on the handle was activated.The distal end of the inner catheter was still in place and so they need to remove the entire system and attempt the stent placement again.They then decided to proceed with a duodenal bend "straight" stent instead of a double pigtail.The procedure was completed with another different device.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the patient and in the stent delivery system 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.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that an advanix biliary stent was used in the hepatic duct for a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, a 10fr x 10cm double pigtail stent was properly loaded onto the advanix 10fr delivery system and positioned over the guidewire.Upon deployment, the radiopaque marker on the inner catheter of the delivery system remained within the hepatic duct even after the green deployment indicator on the handle was activated.The distal end of the inner catheter was still in place and so they need to remove the entire system and attempt the stent placement again.They then decided to proceed with a duodenal bend "straight" stent instead of a double pigtail.The procedure was completed with another different device.There were no patient complications reported as a result of this event.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 stent barb cover over the trailing barb, to assist with stent introduction into the scope.".
Additional Manufacturer Narrative
Block b5 has been corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24183499
• Report Number: 3005099803-2026-00296
• Device Sequence Number: 9702877
• Product Code: FGE
• UDI-Device Identifier: 08714729787051
• UDI-Public: (01)08714729787051(17)261009(10)35027875
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101786
• 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,Followup
• Report Date (Section B): 05/04/2026

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 Model Number: M00532290
• Device Catalogue Number: M00532290
• Device Lot Number: 0035027875
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 04/08/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/19/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic