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

Model Number	M0062502230
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a04 captures the reportable event of scratch at the end of the distal tip.
Event or Problem Description
It was reported that a navigator access sheath device was used in a retrograde intrarenal surgery (rirs) procedure.Reportedly, they noticed a scratch at the end of the distal tip.The procedure was completed with another of the same device.No further information reported.
Event or Problem Description
It was reported that a navigator access sheath device was about to be used in a retrograde intrarenal surgery (rirs) procedure.During preparation, they noticed a scratch at the end of the outer sheath's distal tip.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h2: additional information: block b5, block d7a and block h8.Block h6: device code a04 captures the reportable event of scratch at the end of the distal tip.
Additional Manufacturer Narrative
Block h6: device code a04 captures the reportable event of scratch at the end of the distal tip.Block h11: investigation results: the returned navigator device was analyzed, and a visual evaluation noted that the device returned in good conditions.During the inspection no damage on the tip was found.Microscopic examination was performed under high magnification, and it was not possible to see a scratch on the device.Based on the investigation results, boston scientific concludes that the reported event was not confirmed as it was not possible to identify any evidence of either the alleged malfunction or any defect on the device.The device history record review confirmed that the device met all manufacturing specifications prior to distribution and there were no manufacturing deviations.Based on analysis results, an investigation conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a navigator access sheath device was about to be used in a retrograde intrarenal surgery (rirs) procedure.During preparation, they noticed a scratch at the end of the outer sheath's distal tip.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: 23069820
• Report Number: 2124215-2025-64841
• Device Sequence Number: 13191666
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: (01)08714729837985(17)270425(10)36378431
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 12/04/2025

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 Model Number: M0062502230
• Device Catalogue Number: M0062502230
• Device Lot Number: 0036378431
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 11/09/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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 Sex: Unknown