MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX? RX DELIVERY SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00533560
Medical Device Problem Codes	Break (1069); 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	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter phone (b)(6) exceeded character limit for the designated.Field.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of the physician used an extraction balloon to remove the detached guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was used in the distal common bile duct to treat a pancreatic cancer during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the advanix stent was successfully deployed.However, the guide catheter was detached when the naviflex delivery system was removed from the patient.The detached guide catheter was removed using rat tooth forceps but was unsuccessful.The physician then used an extraction balloon, and the guide catheter was successfully removed.The stent remains implanted, and the procedure was completed.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.".
Additional Manufacturer Narrative
Block e1: initial reporter phone (b)(6) exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of the physician used an extraction balloon to remove the detached guide catheter.Block h11: product analysis was unable to confirm the reported event of device use of device issue - user error.Additionally, media imaging did not confirm the reported event of guide catheter break as the guide catheter was not seen in the photo.The advanix-naviflex delivery system was not returned for analysis; therefore, a technical analysis could not be performed.A media inspection was performed of a photo provided by the complainant, and it was observed that the pull wire was dislodged.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the guidewire was inside the patient during the attempted deployment as the ifu states "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was used in the distal common bile duct to treat a pancreatic cancer during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the advanix stent was successfully deployed.However, the guide catheter was detached when the naviflex delivery system was removed from the patient.The detached guide catheter was removed using rat tooth forceps but was unsuccessful.The physician then used an extraction balloon, and the guide catheter was successfully removed.The stent remains implanted, and the procedure was completed.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.".

• Brand Name: NAVIFLEX? RX DELIVERY SYSTEM
• 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: 21914472
• Report Number: 3005099803-2025-01749
• Device Sequence Number: 12579498
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)270122(10)35708909
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0035708909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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