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

Model Number	M00534330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was attempted to be implanted during a procedure performed on (b)(6) 2026.During procedure, the pullwire was noticed to be broken.There were no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pullwire break.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of pullwire break.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on the information available and without proper evaluation of the device, it is unknown if the reported events were due to the physician's technique during the procedure, or whether it was related to a device malfunction.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 device was not returned for analysis; therefore, a technical analysis could not be performed.Risk review: a risk review of the advanix biliary stents was completed and confirmed that the events of pullwire break were 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
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was attempted to be implanted during a procedure performed on (b)(6) 2026.During procedure, the pullwire was noticed to be broken.The procedure was completed using another of the same device.There were no patient complications reported as a result of the procedure.***additional information received on march 19, 2026*** it was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was attempted to be implanted in the biliary duct to treat a malignancy during a endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the thread securing the prosthesis to the delivery system broke during the attempt to implant the stent.As a result, the stent was noted to be detached from the delivery system once inside the patient.A snare device was used to successfully retrieve the stent from the patient, and the procedure was completed by using another device of the same model.There were no patient complications as a result of this issue.
Additional Manufacturer Narrative
Based on the new information received on march 19, 2026; it was reported that the wire that broke was the thread holding the prosthesis to the device (suture).Although a clinically significant prolongation or delay of procedure may occur to replace or repair a suture, this event is unlikely to cause or contribute to a death or serious injury if the event were to recur.Therefore, the complaint is considered no longer reportable.Block b5: updated based on additional information received on march 19, 2026.Block h6: imdrf device code has been updated based on additional information received on march 19, 2026.Imdrf impact code has been updated based on additional information received on march 19, 2026.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of suture break.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on the information available and without proper evaluation of the device, it is unknown if the reported event was due to the physician's technique during the procedure, or whether it was related to a device malfunction.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 device was not returned for analysis; therefore, a technical analysis could not be performed.Risk review: a risk review was completed and confirmed that the events of suture break were 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.

• 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: 24645803
• Report Number: 3005099803-2026-01028
• Device Sequence Number: 18693968
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: (01)08714729787426(17)271030(10)37904172
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 0037904172
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 10/30/2025
• 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
• Patient Sex: Unknown