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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Defective Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded double bend stent was used in the hepatic hilum for biliay drainage during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guide catheter broke when the stent was being deployed.The procedure was completed with another advanix biliary preloaded stent.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: a naviflex delivery system was received for analysis; the advanix stent was not returned.Visual inspection found that the pull wire was twisted, and the pull wire cap was detached and was not returned.The guide catheter was detached.Microscopic inspection found that the push catheter suture hole was torn.No other problems were noted with the delivery system.Product analysis confirmed the reported event of catheter-guide break.However, the reported event of stent failure to deploy could not be confirmed because the stent was not returned.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 guidewire was inside the patient during the attempted deployment.However, the ifu states: "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." the investigation concluded that the reported events were due to procedural factors.The stent was most likely not deployed due to the manipulation and/or technique used by the physician, resulting in excessive force used causing the guide catheter break and the additional observed damages on the delivery system.Therefore, taking all available information into consideration, the overall root cause of the reported events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded double bend stent was used in the hepatic hilum for biliary drainage during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guide catheter broke when the stent was being deployed.The procedure was completed with another advanix biliary preloaded stent.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.

• 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: 21225654
• Report Number: 3005099803-2025-00127
• Device Sequence Number: 12652038
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: (01)08714729787433(17)260917(10)34899283
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 09/17/2026
• Device Model Number: M00534340
• Device Catalogue Number: M00534340
• Device Lot Number: 0034899283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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 Sex: Unknown