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

Model Number	M0062502280
Medical Device Problem Codes	Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation result of sheath was fractured.Block h10: investigation result: the returned navigator device was analyzed, and a visual evaluation noted that residues were found in the dilator and sheath indicating use and handling of the device.It was also noted that the tip of the dilator was not bent.Additionally, the sheath and dilator were bent in the middle.Microscopic examination was performed, and it was noticed that the sheath was fractured at the tip section.A whitened areas were observed at the fracture site, indicating at certain point the material was submitted to tension.No other problems with the device were noted.Taking all available information into consideration, the device met all manufacturing specifications required and no abnormalities were reported during the assembly process.However, it is possible to conclude that some operational factors and/or an interaction with an excess force during the procedure could have caused the fracture observed as well as the bending observed in the components, consequently, affecting the performance of the device.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used in the kidney during a transurethral lithotripsy (tul) procedure performed on (b)(6), 2023.During preparation, the tip of the dilator was damaged and bent.The procedure was completed with another navigator access sheath device.There were no patient complication reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of sheath fractured.Please see device analysis results for full investigation details.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17854645
• Report Number: 3005099803-2023-05277
• Device Sequence Number: 3453797
• Product Code: FED
• UDI-Device Identifier: 08714729839088
• UDI-Public: 08714729839088
• 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
• Report Date (Section B): 10/02/2023

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: 01/09/2025
• Device Model Number: M0062502280
• Device Catalogue Number: 250-228
• Device Lot Number: 0030825754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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