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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent and naviflex rx delivery system was to be implanted to treat stones in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure.During the procedure, it was found that it was impossible to deploy the stent.Despite appropriate preparation and attempts to place the device, deployment could not be achieved.Another advanix biliary stent and naviflex rx delivery system was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the device analysis results; guide catheter was detached/separated.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to july 01, 2025, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable investigation finding of catheter guide break block h11: an advanix biliary stent with naviflex rx delivery system was returned for analysis.Visual examination of the returned device revealed that the guide catheter was detached and bent.Microscopic examination was then performed, revealing a torn suture hole on the push catheter.Product analysis confirmed the reported event of stent failure to deploy and as the guide catheter returned detached.The investigation concluded that the reported event and additional observed damages were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Since the stent was not being able to be deployed, excessive pressure to do so bent the guide catheter and damaged the push catheter suture hole by the force the suture was adding to the suture hole.Therefore, a review and analysis of the all the available information indicated 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23441627
• Report Number: 3005099803-2025-05778
• Device Sequence Number: 14648223
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: (01)08714729787433(17)251015(10)32649286
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 10/31/2025

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: 10/15/2025
• Device Model Number: M00534340
• Device Catalogue Number: M00534340
• Device Lot Number: 0032649286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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