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

Model Number	M00534360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted to treat cancer during a stent placement procedure performed on (b)(6) 2025.During the procedure, the prosthesis of the applicator of the advanix biliary device broke.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: the naviflex delivery system was received for analysis.Visual examination of the returned device found the guide catheter was detached.Destructive test was performed, and it was observed that the device hypotube from the pull wire was not assembled correctly into the black guide catheter.A media inspection was performed, and labeled information can be observed, and the device was in a plastic bag.No other damages were noted to the delivery system.Product analysis confirmed the reported event of catheter guide break.The investigation concluded that the reported event was likely due to a quality control deficiency as it was found that the pull wire was not assembled deep enough into the black guide catheter.Boston scientific initiated a non-conforming events prevention (ncep) investigation in june 2024 to further evaluate "catheter guide break" events where the hypotube was not properly bonded to the inside of the guide catheter.The investigation found the guide catheter can slip within the grippers during the bonding cycle after the foot pedal is pushed to begin the cycle.If this is not identified during visual inspection by the operator, this can cause an insufficient bond between hypotube and guide catheter.An immediate action was taken to add a magnification tool to the manufacturing process to improve operator visualization of the bond during the required inspection, and all operators were reminded of the correct method for bond inspections.Although the advanix biliary stent with naviflex rx delivery system continues to perform within anticipated product performance expectations, boston scientific initiated a corrective and preventive action (capa) investigation to further investigate whether any additional corrective actions are warranted.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted to treat cancer during a stent placement procedure performed on (b)(6) 2025.During the procedure, the prosthesis of the applicator of the advanix biliary device broke.Another of the same device was used to complete the procedure.There were no patient complications reported as a result 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21633993
• Report Number: 3005099803-2025-00996
• Device Sequence Number: 9511518
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: (01)08714729787457(17)251022(10)32695319
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/10/2025

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 Expiration Date: 10/22/2025
• Device Model Number: M00534360
• Device Catalogue Number: M00534360
• Device Lot Number: 0032695319
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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: 29 YR
• Patient Sex: Male