MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Navigator HD; Endoscopic Access Overtube, Gastroenterology-Urology

Model Number	M0062502230
Medical Device Problem Codes	Nonstandard Device (1420); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a navigator was used during a procedure.Reportedly, it was found that the tip of the dilator was damaged.The procedure was completed with another of the same device with no patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a020102 captures the reportable event of tip damaged.Block h11: pi analysis upon receipt at our quality assurance laboratory, this access sheath underwent a thorough analysis.The device was visually and microscopically inspected.During the analysis, it was found that the tip was flattened and kinked, which was also confirmed when examining the device under magnification.Additionally, the sheath returned kinked.The device history record review was completed and confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A review of the navigator hazard analysis was completed and confirmed that the events of device kinked, sheath bent/kinked and tip damaged were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the kink identified in the sheath and the flattened tip could have caused by excess of force applied to the device such as operational factors during their use.Due to this, the events of sheath bent/kinked and tip damaged will be assigned a conclusion code of adverse event related to procedure.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Given this information, it is determined the investigation findings did not lead to a clear conclusion about the cause of the failure, all compiled information on this investigation determines that the investigation conclusion code is cause not established.

• 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: 50852828
• Report Number: 2124215-2026-50383
• Device Sequence Number: 9651378
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: M0062502230
• Device Catalogue Number: M0062502230
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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