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

Model Number	M00534330
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h11: an advanix biliary preloaded duodenal bend stent was received for analysis.Visual inspection found that the suture and the stent were detached.Microscopic inspection observed that the stent suture hole was torn.No other problems were noted with the device.Product analysis confirmed the reported event of stent failure to deploy.The reported event and observed failures were likely caused by the pressure when trying to deploy the stent, which could have been due to the physician's technique or tortuosity of the procedure.It is most likely that when the device could not deploy the stent, the stent suture hole was damaged by the pressure that the suture was adding to the suture hole.Since the suture hole was torn, the suture was most likely stuck in the suture hole, which resulted in the stent being unable to deploy.Therefore, a review and analysis of all available information indicated 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 delivery system duodenal bend stent was used during a procedure performed on (b)(6) 2025.During the procedure, the stent was unable to deploy.There were no known patient complications due to this event.Note: no further information has been obtained despite good faith efforts.This event has been deemed an mdr-reportable event based on the investigation results which revealed that the stent was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h11 (device analysis) has been corrected.Block h11: an advanix biliary preloaded duodenal bend stent was received for analysis.Visual inspection found that the suture was detached.Microscopic inspection observed that the stent suture hole was torn.No other problems were noted with the device.Product analysis confirmed the reported event of stent failure to deploy.The reported event and observed problems were likely caused by the pressure when trying to deploy the stent, which could have been due to the physician's technique or tortuosity of the procedure.It is most likely that when the device could not deploy the stent, the stent suture hole was damaged by the pressure that the suture was adding to the suture hole.Since the suture hole was torn, the suture was most likely stuck in the suture hole, which resulted in the stent being unable to deploy.Therefore, a review and analysis of all available information indicated 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 delivery system duodenal bend stent was used during a procedure performed on (b)(6) 2025.During the procedure, the stent was unable to deploy.There were no known patient complications due to this event.Note: no further information has been obtained despite good faith efforts.This event has been deemed an mdr-reportable event based on the investigation results which revealed that the stent was detached.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: 22331311
• Report Number: 3005099803-2025-02884
• Device Sequence Number: 13157287
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: (01)08714729787426(17)261107(10)35336933
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/30/2025

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 Model Number: M00534330
• Device Catalogue Number: M00534330
• Device Lot Number: 0035336933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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