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

Model Number	M00534650
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded center bend stent was used in the bile duct to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the steel stylet could not be retracted to adjust the guide catheter of the stent.The procedure was completed with another advanix biliary preloaded stent.There were 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 that the guide catheter was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable investigation findings of catheter-guide break.Block h11: an advanix biliary preloaded center bend stent was received for analysis.Visual inspection found that the push catheter suture hole was torn.During functional inspection, the pull wire was able to be retracted and extended.However, when the pull wire was completely inside the push catheter, it was observed that the guide catheter was unable to be extended.Destructive inspection was performed, and it was found that the pull wire was broken which resulted in the guide catheter being detached.The guide catheter was not returned.No other problems were noted with the device.Product analysis did not confirm the reported event of pull wire retraction problem as it could be retracted and extended during functional inspection.The investigation concluded that the reported event and additional observed damages were likely due to procedure factors encountered.It is possible that during the attempted deployment, the tortuosity of the procedure or the physician's technique caused the device to be unable to work properly, resulting in the physician using more force and causing the reported event and additional observed damages.Taking all available information into consideration, the investigation concluded that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• 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: 21549162
• Report Number: 3005099803-2025-00848
• Device Sequence Number: 8180015
• Product Code: FGE
• UDI-Device Identifier: 08714729787204
• UDI-Public: 08714729787204
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: M00534650
• Device Catalogue Number: M00534650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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