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

Model Number	M00534360
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted during a procedure on (b)(6) 2023.During the procedure, the stent separated from the holder by itself and got stuck in the endoscope.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 finding of stent damaged.Please see block h10 for the full investigation details.
Additional Manufacturer Narrative
E1: the initial reporter's facility name is (b)(6).The initial reporter's address is 29 av du mal delattre de tassigny.H6: imdrf device code a0406 captures the reportable investigation finding of stent damage.H10: the advanix biliary stent and naviflex rx delivery system were received for analysis.Visual inspection revealed that the stent was damaged.No other damages were noted with the stent or the delivery system.Product analysis was unable to confirm the reported events of stent premature deployment and device or device component entrapment because these events occurred during the procedure and were not possible to replicate in the laboratory of analysis.However, the investigation concluded that the additional investigation finding of a damaged stent was most likely due to procedural factors such as lesion characteristics, the handling of the device, or the technique used by the physician (force applied).Taking all available information into consideration, the root cause of the reported clinical observation is no problem detected.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18952015
• Report Number: 3005099803-2024-01122
• Device Sequence Number: 15223584
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: 08714729787457
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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: 10/16/2025
• Device Model Number: M00534360
• Device Catalogue Number: 3436
• Device Lot Number: 0032654950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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