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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent and naviflex rx delivery system was used in the common bile duct to treat stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2024.The patient's anatomy was not too tight.During the procedure, the stent was difficult to deploy, so kocher forceps were used, which allowed the stent to be released but caused a piece of the guide catheter to break off.Eventually, the stent was correctly placed, and the piece of the guide catheter was removed using foreign body forceps.The stent remains implanted inside the patient.There were no patient complication reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the additional device used to remove the broken guide catheter.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the additional device used to remove the broken guide catheter.Block h11: an advanix biliary rx preloaded stent was received for analysis.Upon visual inspection, it was observed that the guide catheter was detached, the pullwire was kinked and bent, the push catheter was bent, and the suture hole on the push catheter was torn.No other damage was noted on the device.Product analysis confirmed the reported event of a detached guide catheter.The investigation determined that the reported event and the observed damage were most likely the result of excessive force applied to device during deployment.Contributing factors may include the physician's technique and/or procedural tortuosity, which may have limited the device's performance and led to the observed failures.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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent and naviflex rx delivery system was used in the common bile duct to treat stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was not too tight.During the procedure, the stent was difficult to deploy, so kocher forceps were used, which allowed the stent to be released but caused a piece of the guide catheter to break off.Eventually, the stent was correctly placed, and the piece of the guide catheter was removed using foreign body forceps.The stent remains implanted inside the patient.There were no patient complication reported as a result of the 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: 19202363
• Report Number: 3005099803-2024-01893
• Device Sequence Number: 15465983
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: (01)08714729787433(17)260115(10)33220413
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2026
• Device Model Number: M00534340
• Device Catalogue Number: M00534340
• Device Lot Number: 0033220413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown