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

Model Number	M0062502220
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	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a navigator access sheath device was used during a transurethral lithotripsy procedure.During the procedure, an attempt was made to insert a ureteroscope inside the sheath, however a severe resistance was felt inside the lumen of the sheath.The physician suspected an abrasion or peeling of the coating inside the sheath.The procedure was completed with a different device without patient complications.
Additional Manufacturer Narrative
Block h6: device code a040506 captures the reportable event of sheath peeled.
Additional Manufacturer Narrative
Block h6: device code a040506 captures the reportable event of sheath peeled.Block h11: investigation result the returned navigator device was analyzed, and a visual evaluation noted that only the sheath was returned for analysis.It was also noted that the sheath was bent/kinked at the proximal section.Destructive test was performed, and the device was cut in half.The pieces were inspected with light internally and it was noticed that the inner lining was peeled/sheared.With all the available information, boston scientific concludes that the reported event of sheath peeled was confirmed.These could be related to handling and manipulation of the device during procedure, it is probable that an excess of force applied to the device such as operational factors during their use could lead to bend/kink the sheath that could have consequently caused the peeled/sheared the inner lining which affects the performance of the device.Based on the analysis results, a conclusion code of adverse event related to procedure was assigned to this investigation because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that a navigator access sheath device was used during a transurethral lithotripsy procedure.During the procedure, an attempt was made to insert a ureteroscope inside the sheath, however a severe resistance was felt inside the lumen of the sheath.The physician suspected an abrasion or peeling of the coating inside the sheath.The procedure was completed with a different device without 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: 20825334
• Report Number: 2124215-2024-75559
• Device Sequence Number: 12713783
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• 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,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: 07/17/2026
• Device Model Number: M0062502220
• Device Catalogue Number: M0062502220
• Device Lot Number: 0034449929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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