MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Navigator; Endoscope And/Or Accessories

Model Number	M0062502031
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a navigator access sheath device was set to be used during a lithotripsy procedure.Reportedly, upon opening it was found that the sheath crumbled and began to chip before use.Additionally, the sheath was also noticed to be kinked.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code 150103 captures the reportable event of sheath peeled.

• Brand Name: Navigator
• Common Device Name: Endoscope And/Or Accessories
• 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: 50842276
• Report Number: 2124215-2026-50060
• Device Sequence Number: 10050867
• Product Code: FED
• UDI-Device Identifier: 08714729469582
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K030956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: M0062502031
• Device Catalogue Number: 250-203
• Device Lot Number: 0036100056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 03/19/2025
• 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