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

Model Number	M0062502230
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a navigator access sheath device was used during a lithotomy under flexible endoscope procedure.During the procedure, the ureteral sheath was damaged.Additionally, it was noted that the tip of the device was cracked.The procedure was completed with another of the same device with no patient complications.
Additional Manufacturer Narrative
Block h6: device code a04 captures the reportable event of tip damaged.
Additional Manufacturer Narrative
Block h6: device code a04 captures the reportable event of tip damaged.Block h11: investigation result the returned navigator device was analyzed, and a visual evaluation noted that both sheath and dilator were returned for analysis.Additionally, both sheath and dilator returned bent/kinked at the proximal section.Microscopic examination was performed under magnification, and it was possible to see that the tip was flattened.With all the available information, boston scientific concludes that the reported event was confirmed.It is possible that this 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 bent/kink the sheath and dilator that could eventually cause the flattened observed on the tip.Additionally, it is important to highlight that the ifu includes on its precaution section do not bend or kink the dilator or sheath prior to placement, to do so could damage the integrity of the device that consequently could affect the device performance.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 lithotomy under flexible endoscope procedure.During the procedure, the ureteral sheath was damaged.Additionally, it was noted that the tip of the device was cracked.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: 20885507
• Report Number: 2124215-2024-77345
• Device Sequence Number: 8934197
• Product Code: FED
• UDI-Device Identifier: 08714729837985
• UDI-Public: 08714729837985
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/08/2025

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: 02/21/2026
• Device Model Number: M0062502230
• Device Catalogue Number: M0062502230
• Device Lot Number: 0033482547
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 56 KG