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

Model Number	M00532210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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-naviflex biliary stent was implanted during a procedure performed on (b)(6) 2025.During the procedure, the black inner sheath was detached during deployment.There was no patient complication reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks b1, d4 unique identifier (udi) , h6 (evaluation conclusion code) have been updated based on additional information received on 27mar2025.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-naviflex biliary stent was implanted during a procedure performed on (b)(6) 2025.During the procedure, the black inner sheath was detached during deployment.There was no patient complication reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks b5 and h6 (device code) have been corrected.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent was to be implanted to treat a stricture in the biliary during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent was not deployed.The procedure was completed with another of the same device.There was no patient complication 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: an advanix stent with naviflex delivery system was returned for analysis.Visual examination of the returned device found that only the guide catheter returned, and it had a stent attached to it, the tip of the guide catheter was torn, and the stent was buckled accordion.No other problems were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy as the stent was returned attached to the guide catheter.The investigation concluded that the reported event and additional observed damage of catheter guide break were likely due to factors encountered during the procedure like tortuosity, handling of the device and the technique used by the physician (force applied).Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent was to be implanted to treat a stricture in the biliary during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent was not deployed.The procedure was completed with another of the same device.There was no patient complication 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: 21710127
• Report Number: 3005099803-2025-01305
• Device Sequence Number: 10010184
• Product Code: FGE
• UDI-Device Identifier: 08714729786993
• UDI-Public: (01)08714729786993(17)261112(10)35267338
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101786
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/12/2025

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: M00532210
• Device Catalogue Number: M00532210
• Device Lot Number: 0035267338
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 03/27/2025; 05/20/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 03/31/2025; 04/18/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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