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

Model Number	M0062502260
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a020504 captures the reportable event of package torn.
Event or Problem Description
It was reported that a navigator access sheath device was to be use on a procedure; however, it was noticed that the tape inside of the cardboard box is not properly attached and stuck to the product.Reportedly, the side of the box was torn.There was no patient or procedure involved.
Additional Manufacturer Narrative
Block h6: device code a020504 captures the reportable event of package torn.Block h11: investigation results the navigator device was returned in unopened box.A visual examination noted that the seal of the box returned in good condition; however, one side of the box was ripped and wrinkled confirming the reported event related to damaged packaging.Based on the investigation, it is possible that the way in which the device was handled and manipulated during the processes of shipping/receiving and/or storage could have caused packaging ripped and wrinkled at one side of the box.The device history record review confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the analysis results, a conclusion code of cause traced to transport/storage since problems traced to the inappropriate transport or storage of the device.
Event or Problem Description
It was reported that a navigator access sheath device was to be use on a procedure; however, it was noticed that the tape inside of the cardboard box is not properly attached and stuck to the product.Reportedly, the side of the box was torn.There was no patient or procedure involved.No further information has been obtained despite good faith efforts.

• 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: 23115970
• Report Number: 2124215-2025-64852
• Device Sequence Number: 21156735
• Product Code: FED
• UDI-Device Identifier: 08714729837558
• UDI-Public: (01)08714729837558(17)270716(10)36979398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: M0062502260
• Device Catalogue Number: M0062502260
• Device Lot Number: 0036979398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/02/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown