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

Model Number	M0062502220
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a navigator access sheath device was set to be used in a procedure.Reportedly, an eyelash hair was found in the package.There was no patient or procedure involved.
Additional Manufacturer Narrative
Block h6: device code a1802 captures the reportable event of foreign matter.

• 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: 50223055
• Report Number: 2124215-2026-43162
• Device Sequence Number: 20195092
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: (01)08714729837978(17)271102(10)37855483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: M0062502220
• Device Catalogue Number: M0062502220
• Device Lot Number: 0037855483
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 11/02/2025
• 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