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

Model Number	M00534330
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
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.We've sent good faith effort attempts to obtain all missing information.If additional details become available, a supplemental report will be submitted.Block e1: this event was reported by the bsc sales representative.The healthcare facility is: (b)(6) hosp (b)(6).Address: (b)(6).Phone: (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.
Event or Problem Description
Note: related advanix biliary stent, autotome and hydra jagwire complaints are being reported under records (b)(4) and (b)(4).It was reported to boston scientific corporation that two advanix rx biliary stent with naviflex rx delivery system were attempted to be implanted during a stent placement procedure performed on (b)(6) 2026.During the procedure, the customer experienced difficulty deploying two plastic biliary stents over a hydrawire.The guidewire could not be advanced beyond the stent/suture/pusher assembly.The customer retracted the black guide catheter to reposition it prior to advancing it over the wire and attempted deployment multiple times without success.Force was subsequently applied, resulting in suture breakage and stent misdeployment.The procedure was aborted and no stent was placed.There were no patient complications reported as a results of this event.

• 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: 25363989
• Report Number: 3005099803-2026-02262
• Device Sequence Number: 18805143
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: (01)08714729787426
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/29/2026

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: 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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