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 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.Block h11: investigation results: based on the information available, boston scientific could not confirm the reported events of device difficult to advance guidewire, suture break and stent premature deployment.The product was not returned for analysis to identify any potential defect with the device.Additionally, without proper evaluation of the device, the most probable causes that contributed to the events remain unknown.Regarding the event cancelled/rescheduled - post sedation/sedation unknown, this occurred during the procedure; however, the most probable cause of this reported issue cannot be established due to lack of evidence.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the complaint device was not returned; therefore, product analysis could not be performed.As a result, and due to the lack of available evidence, boston scientific was unable to confirm the reported event.Risk review: a risk review was completed and confirmed that the event of cancelled/rescheduled - post sedation/sedation unknown was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
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: 25363995
• Report Number: 3005099803-2026-02261
• Device Sequence Number: 10654577
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: (01)08714729787426(17)280311(10)38899794
• 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
• Device Lot Number: 0038899794
• 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
• Date Device Manufactured: 03/12/2026
• 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