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

Model Number	M0062502250
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a04 captures the reportable event of tip damaged.
Event or Problem Description
It was reported that a navigator access sheath device was set to be used during a ureteroscopy intervention procedure.During preparation, upon opening the package, they noticed that the coating on the tip of the sheath was partially peeled off.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a04 captures the reportable event of tip damaged.Block h11: investigation result- the returned navigator device was analyzed and noted that both sheath and dilator were returned for analysis.Media analysis shows that one navigator with a scraped in the tip.Microscopic examination was performed under magnification and observed the device before and after moistened with water.No voids were visible in the device.Functional examination was performed with no problem identified with the device and the device was found to be in proper condition.Additionally, the sheath and dilator surfaces were moistened with water and dilator became slippery which indicates that the coating was properly applied while no dry areas were detected on the sheath.With all available information boston scientific concludes that the reported event was not confirmed as it was not possible to identify any evidence of the reported issue or any defect on the device.During the device and media analysis, and including the product record review results, the device meets all required manufacturing specifications and successfully passed all controls and inspections.No abnormalities were reported during the assembly process.Based on analysis results, an investigation conclusion code of device problem excluded was assigned to this investigation.
Event or Problem Description
It was reported that a navigator access sheath device was set to be used during a ureteroscopy intervention procedure.During preparation, upon opening the package, they noticed that the coating on the tip of the sheath was partially 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: 23873092
• Report Number: 2124215-2025-92495
• Device Sequence Number: 4451196
• Product Code: FED
• UDI-Device Identifier: 08714729837992
• UDI-Public: (01)08714729837992(17)251130(10)32970113
• 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): 02/27/2026

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 Expiration Date: 11/30/2025
• Device Model Number: M0062502250
• Device Catalogue Number: M0062502250
• Device Lot Number: 0032970113
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 70 KG