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

Model Number	M00533580
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	01/05/2026
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
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a naviflex rx delivery system was used in the hepatic duct for a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, a 10fr x 10cm double pigtail stent was properly loaded onto the advanix 10fr delivery system and positioned over the guidewire.Upon deployment, the radiopaque marker on the inner catheter of the delivery system remained within the hepatic duct even after the green deployment indicator on the handle was activated.The distal end of the inner catheter was still in place and so they need to remove the entire system and attempt the stent placement again.They then decided to proceed with a duodenal bend "straight" stent instead of a double pigtail.The procedure was completed with another different device.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the patient and in the stent delivery system 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 (device codes) has been corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Block h11: investigation results: based on the available information, boston scientific could confirm the reported event of catheter guide break.The returned naviflex rx delivery system with stent was analyzed, and product evaluation showed the guide catheter kinked and detached from the hypotube.It is likely that the catheter became stuck in either the push catheter or the scope, and excessive force applied during stent deployment most likely caused the guide catheter to detach during the procedure.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: a naviflex rx delivery system with stent was received for analysis.Visual examination showed that the guide catheter was kinked and had detached from the hypotube.No other device problems were noted.Risk review: a risk review was completed and confirmed that the event of catheter guide break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on events.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a naviflex rx delivery system was used in the hepatic duct for a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, a 10fr x 10cm double pigtail stent was properly loaded onto the advanix 10fr delivery system and positioned over the guidewire.Upon deployment, the radiopaque marker on the inner catheter of the delivery system remained within the hepatic duct even after the green deployment indicator on the handle was activated.The distal end of the inner catheter was still in place and so they needed to remove the entire system and attempt the stent placement again.They then decided to proceed with a duodenal bend "straight" stent instead of a double pigtail stent.The procedure was completed with another different device.There were no patient complications reported as a result of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24183506
• Report Number: 3005099803-2026-00295
• Device Sequence Number: 18522680
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: (01)08714729787105(17)270221(10)35938232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/24/2026

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 Model Number: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0035938232
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic