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

Model Number	M0062502220
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device problem code a0414 captures the reportable investigation result of sheath torn.Block h10: investigation result the returned navigator device was analyzed, and a visual evaluation noted that the sheath was torn.Microscopic examination was performed, and it was noticed that the device was slightly bent/kinked.Additionally, whitened areas were observed, indicating that the material was submitted to tension.No other issues were found.Based on the available information, the reported event was not confirmed.However, it was found that the navigator sheath was torn, and the device was slightly bent/kinked.Additionally, whitened areas were observed, indicating the material was submitted to tension.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 its use could produce the investigation findings on the device affecting its performance.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used during a kidney biopsy/stent placement performed on (b)(6) 2023.During the procedure, it was noticed that the device had a big crack in it when they went to use it.The procedure was completed with another navigator access sheath device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation findings of sheath torn.Please see block h10 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18424496
• Report Number: 2124215-2023-74138
• Device Sequence Number: 7771464
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: 08714729837978
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

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: 05/02/2025
• Device Model Number: M0062502220
• Device Catalogue Number: 250-222
• Device Lot Number: 0031547666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown