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

Model Number	M00534600
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 is being used to capture the reportable investigation results of guide catheter and pull wire detached.Block h11: an advanix biliary stent with naviflex delivery system was returned for analysis.Visual examination of the returned device found the guide catheter detached.A destructive test was performed, and the pull wire was found detached.In addition, the guide catheter and pull wire were kinked.No other problems were noted to the stent and delivery system.The reported event of stent failure to deploy was confirmed.The investigation concluded that the reported event and additional observed damages were likely due to factors encountered during the procedure.The tortuosity of the procedure or the physician's technique may have made the stent not able to be deployed, which consequently made the physician use more force to deploy the stent and by this manipulation, causing the additional observed damages.Therefore, a review and analysis of all available information indicate the most probable cause is adverse event related to procedure.
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 during a procedure performed on an unspecified date.During the procedure the stent was unable to be deployed.There was no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed a guide catheter and pull wire detachment.Please see block h11 for full investigation details.

• 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: 21652679
• Report Number: 3005099803-2025-01136
• Device Sequence Number: 7480214
• Product Code: FGE
• UDI-Device Identifier: 08714729787150
• UDI-Public: 08714729787150
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K203162
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: 10/19/2025
• Device Model Number: M00534600
• Device Catalogue Number: M00534600
• Device Lot Number: 0032685646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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 Sex: Unknown