MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0062502040
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a procedure performed on (b)(6), 2024.During the procedure, the urethral sheath ruptured.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of sheath torn.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of sheath torn.Block h11: investigation result: the returned navigator device was analyzed, and a visual evaluation noted that both sheath and dilator were returned for analysis.Microscopic examination was performed, and the sheath was torn at the proximal section thereby confirming the reported event.No other problems with the device were noted.Based on the available information 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 tear the sheath.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a procedure performed on (b)(6) 2024.During the procedure, the urethral sheath ruptured.No patient complications have been reported as a result of this event.

• Brand Name: NAVIGATOR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• 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: 19075919
• Report Number: 2124215-2024-21550
• Device Sequence Number: 17834964
• Product Code: KOD
• UDI-Device Identifier: 08714729429968
• UDI-Public: 08714729429968
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030956
• 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): 07/12/2024

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: 08/01/2025
• Device Model Number: M0062502040
• Device Catalogue Number: 250-204
• Device Lot Number: 0032136445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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