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

Model Number	M00534590
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was implanted in the common bile duct to treat drainage during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when the physician removed the guide wire in preparation for releasing the stent, it was found that it could not be released.The inner sheath was then forcibly pulled out, causing damage to the delivery system.Additional information stated that the pusher wire had been deformed.The procedure was completed with another device of the same type.There were no known patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g4: premarket 510(k): k101314, k203162 - reported here as it exceeded the maximum character limit for the designated field.Block h6: imdrf device code a0401 is being used to capture the reportable event of stent break.Block h11: an advanix rx biliary preloaded stent was received for analysis.During the device analysis, the device was returned with the guide catheter detached, kinked, and stretched.The pull wire was dislodged from the push catheter.Additionally, during the destructive test, it was observed that the pull wire was kinked near the hypo tube.Furthermore, a photo of the device was provided.No other issues were noted with the delivery system.Product analysis confirmed the events of stent failure to deploy and pull wire kinked.Analysis also found that the pull wire was dislodged out of the push catheter and was kinked near the hypotube.The investigation found it likely that when they tried to deploy the stent, the tortuosity of the procedure or the physician technique made the device not able to deploy the stent, which made the physician use more force to deploy the stent and by this manipulation, the guide catheter ended up getting kinked, stretched and later the guide catheter wouldn't hold this pressure getting detached.The force applied to deploy the stent combined with the conditions seen on the device probably made the pull wire get dislodged out of the push catheter and become kinked by the pressure that it was used during deployment.Therefore, a review and analysis of all compiled information from this investigation determine that the most probable cause is "adverse event related to procedure.".

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21307170
• Report Number: 3005099803-2025-00270
• Device Sequence Number: 21051879
• Product Code: FGE
• UDI-Device Identifier: 08714729787143
• UDI-Public: 08714729787143
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 02/04/2025

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: 05/10/2026
• Device Model Number: M00534590
• Device Catalogue Number: M00534590
• Device Lot Number: 0034281649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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