MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	M0062502230
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040506 captures the reportable event of sheath peeled.
Event or Problem Description
It was reported that a navigator access sheath device was about to be use during ureteral lithotripsy procedure.During unpacking it was found that the ureteral sheath inner core was peeled off.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a040506 captures the reportable event of sheath peeled.Block h11: investigation results.The returned navigator device was analyzed, and it was noted that both the sheath and dilator were returned for analysis.A visual and microscopic examination was performed under magnification, and it was observed the device before moistened with water and after moistened.It also noticed different sections with (voids) without coating in the sheath.Additionally, it was found that the tip of the dilator was kinked.A functional examination was performed, and the device sheath and dilator surfaces were moistened with water.The dilator became slippery indicating coating was applied to the dilator.The sheath did not happen the same, some areas of the sheath became slippery, however some other areas of the surface of the sheath felt dry.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.The ifu states, to minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.With all the available information, boston scientific concludes that the reported event of sheath peeled was confirmed.Based on the investigation, the sheath was found with voids without coating, and it was felt dry.As per replicate, if a force was applied on the sheath surface once the device coating is activated, the coating can be removed, causing voids along the sheath.This failure was able to be re-created and found no evidence of a misuse.However, it is possible that the force applied during the manipulation on the device once it had the coating activated caused the voids on the sheath, once voids are in the sheath, it would affect the performance of the device.Additionally, during manufacturing, the dilator or sheath are inspected per cosmetic procedure.These steps of the process would assure the proper coating on the sheath and dilator.However, the observed dilator tip kinked had no clear indications that the kinked dilators were occurring during the tipping process.If the dilator tip is bent, this would cause resistance, or the mandrel plug would not be able to advance in the tip of the dilator.These inspections ensure the integrity of the tip and would catch any dilators that were kinked or bent during processing.Taking all available information into consideration, the most probable cause of this complaint is unintended use error caused or contributed to event, indicating that interaction between the user and the device caused or contributed to the error.
Event or Problem Description
It was reported that a navigator access sheath device was about to be use during ureteral lithotripsy procedure.During unpacking it was found that the ureteral sheath inner core was peeled off.The procedure was completed with another of the same device with no patient complications.

• Brand Name: NAVIGATOR HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21772956
• Report Number: 2124215-2025-20239
• Device Sequence Number: 18553650
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: (01)08714729837985(17)260225(10)33500094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140323
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: 02/25/2026
• Device Model Number: M0062502230
• Device Catalogue Number: M0062502230
• Device Lot Number: 0033500094
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 60 KG