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

Model Number	M00535060
Medical Device Problem Codes	Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of guide catheter break and pull wire break.Block h11: the naviflex rx pancreatic delivery system was returned for analysis.Visual examination of the returned device revealed that the guide catheter was bent.The delivery system also did not have a suture, as it was not a preloaded delivery system.A functional inspection was performed, and the guide catheter showed no movement when extending or retracting the pull wire.During destructive testing and microscopic inspection, it was observed that the pull wire was broken within the delivery system, which caused the guide catheter to detach.No other issues were noted with the delivery system.Product analysis could not confirm the reported event of suture deployment issue.The investigation concluded that the observed damages of pull wire break and guide catheter break were most likely due to procedural factors encountered during the procedure.It may be that tortuosity of the procedure, and the manipulation or technique used by the physician, limited the performance of the device and contributed to the observed damages.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pancreatic delivery system was used to treat strictures during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the guide catheter became stuck in the stent and the suture loop did not come out of the guide catheter.The procedure was completed with another of same device.There were no patient complications as a result of this event.Note: this event has been deemed a reportable event based on the investigation findings of pull wire break and guide catheter break.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of guide catheter break and pull wire break.Block h11:device analysis has been corrected.The naviflex rx pancreatic delivery system was returned for analysis.Visual examination of the returned device revealed that the guide catheter was bent.A functional inspection was performed, and the guide catheter showed no movement when extending or retracting the pull wire.During destructive testing and microscopic inspection, it was observed that the pull wire was broken within the delivery system, which caused the guide catheter to detach.No other issues were noted with the delivery system.Product analysis could not confirm the reported event of pull wire retraction problem.The investigation concluded that the observed damages were most likely due to procedural tortuosity or the physician's technique prevented the device from successfully deploying the stent.As a result, the physician applied additional force, which led to detachment of the pull wire and caused the guide catheter to break off from the delivery system.It is also possible that the stent could not be deployed if the guide catheter had already been bent prior to the deployment attempt, potentially due to the technique used earlier in the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pancreatic delivery system was used to treat strictures during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the guide catheter became stuck in the stent and the suture loop did not come out of the guide catheter.The procedure was completed with another of same device.There were no patient complications as a result of this event.Note: this event has been deemed a reportable event based on the investigation findings of pull wire break and guide catheter break.Please see block h11 for full investigation details.

• 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: 22777128
• Report Number: 3005099803-2025-03644
• Device Sequence Number: 9585463
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: (01)08714729856221(17)260408(10)35095085
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K133700
• 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): 08/13/2025

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: 04/08/2026
• Device Model Number: M00535060
• Device Catalogue Number: M00535060
• Device Lot Number: 0035095085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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