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

Model Number	M0062502230
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a navigator access sheath device was used during a retrograde intrarenal surgery (rirs) procedure.During the procedure, it was noticed that the inside was sticking out sharply and can be seen through scope.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
H6: device code a040506 captures the reportable event of sheath peeled.
Additional Manufacturer Narrative
Device code a040506 captures the reportable event of sheath peeled.Investigation results: the returned navigator device was analyzed, and a visual evaluation noted that both sheath and dilator were returned in good condition.Microscopic examination was performed under magnification, and it was possible to see that the sheath was bent/kinked in the center.Additionally, some whitened areas were observed on the bent/kinked indicating the device was submitted to tension.Destructive test was performed, and the device was cut in three sections, however, no evidence of detachment of the inner lining was found.It was not possible to identify any evidence of the alleged issue on the device since no evidence of detachment of the inner lining was found inside the sheath, therefore, the reported device allegation could not be confirmed.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Based on analysis results, a 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 used during a retrograde intrarenal surgery (rirs) procedure.During the procedure, it was noticed that the inside was sticking out sharply and can be seen through scope.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: 20735741
• Report Number: 2124215-2024-71997
• Device Sequence Number: 8287894
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• 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
• Report Date (Section B): 01/13/2025

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 Expiration Date: 10/17/2025
• Device Model Number: M0062502230
• Device Catalogue Number: M0062502230
• Device Lot Number: 0032662613
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male