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

Model Number	M00534260
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable media analysis finding of stent barb torn.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary was implanted in the bile duct for bile drainage during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noted that there was a thread hanging on the stent.The advanix biliary stent remains implanted, and the procedure was completed.There were no reported patient complications as a result of this event.Note: this event has been deemed an mdr reportable event based on a media inspection of the photo provided by the customer that determined the stent barb was torn.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable media analysis finding of stent barb torn.Block h10: the naviflex rx delivery system was returned for analysis.The advanix biliary stent was not received for analysis.Visual inspection found that the guide catheter was bent and the push catheter suture hole was torn.Media analysis of the photo of the stent inside the patient found that the stent barb was bent and torn; however, the suture was not visible.No other damages were noted with the delivery system.Product analysis confirmed the reported events of stent barb irregular shape, stent barb torn material, and user error; however, the reported event of suture break was not confirmed because it could not be observed during analysis.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the advanix biliary stent with naviflex rx delivery system instructions for use (ifu), "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." thus, the user did not follow the manufacturer's instructions.Additionally, the investigation concluded that the deformed and torn stent barb and the additional investigation findings of the guide catheter being kinked and the push catheter suture hole being torn were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary was implanted in the bile duct for bile drainage during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, it was noted that there was a thread hanging on the stent.The advanix biliary stent remains implanted, and the procedure was completed.There were no reported patient complications as a result of this event.Note: this event has been deemed an mdr reportable event based on a media inspection of the photo provided by the customer that determined the stent barb was torn.

• 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: 18727964
• Report Number: 3005099803-2024-00556
• Device Sequence Number: 17577878
• Product Code: FGE
• UDI-Device Identifier: 08714729787358
• UDI-Public: 08714729787358
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 03/19/2024

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: 08/02/2025
• Device Model Number: M00534260
• Device Catalogue Number: 3426
• Device Lot Number: 0032146861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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