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

Model Number	M00534270
Medical Device Problem Codes	Positioning Failure (1158); Entrapment of Device (1212); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a advanix biliary stent with naviflex delivery system was implanted to treat a bile duct stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the inner core of the steel wire was stuck, and the stent could not be released.Another advanix-naviflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed an mdr-reportable event based on investigation results, which revealed that the stent barb was torn.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h11: an advanix-naviflex biliary stent and delivery system were returned for analysis.Visual examination of the returned device found the stent barb torn, the pull wire kinked, the push catheter suture hole was torn and stent suture hole torn.Functional inspection was performed by passing a guide wire through the device with no problems.No other problems were noted to the stent and delivery system.The reported event of device guidewire stuck could not be confirmed.The investigation concluded that the reported events and additional observed damages were most likely due using the device in a manner inconsistent with the instruction.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the barb flap cover was not used to insert the device through the biopsy cap.The ifu states "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to the physician not following the instruction for use during the procedure.The barb flap cover wasn't used during insertion through the biopsy cap could have caused the stent barb torn, which limited the performance of the device and contributed to the reported event and observed damages.Therefore, the most probable cause is failure to follow instructions.

• 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: 21741145
• Report Number: 3005099803-2025-01393
• Device Sequence Number: 18301549
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: (01)08714729787365(17)260711(10)34514435
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 07/11/2026
• Device Model Number: M00534270
• Device Catalogue Number: M00534270
• Device Lot Number: 0034514435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 52 KG