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

Model Number	M0062502260
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a navigator was used during a retrograde intrarenal surgery procedure performed on (b)(6) 2023.During the procedure, a resistance or scraping was felt against the inner wall of the outer sheath when the inner sheath was inserted.The procedure was completed with another navigator device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Imdrf device code a040506 captures the reportable event of sheath peeled.
Event or Problem Description
It was reported to boston scientific corporation that a navigator was used during a retrograde intrarenal surgery procedure performed on (b)(6) 2023.During the procedure, a resistance or scraping was felt against the inner wall of the outer sheath when the inner sheath was inserted.The procedure was completed with another navigator device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Additional information received on april 20, 2023: it was reported that the navigator device was used in the ureter during a retrograde intrarenal surgery procedure.
Additional Manufacturer Narrative
Block h2: correction: b5 (describe event or problem) and d7a (sud reprocessed and reused?).Block h6: imdrf device code a040506 captures the reportable event of sheath peeled.
Additional Manufacturer Narrative
Block h6: imdrf device code a040506 captures the reportable event of sheath peeled.Block h10: investigation results: the returned navigator device was analyzed, and a visual evaluation found that the device was in good condition.A functional test was performed and the sheath did not feel any resistance.Microscopic inspection was also performed and it was observed that the evidence of the inner sheath peeled was not found.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of sheath peeled was not confirmed.After conducting a thorough investigation into the device, it was determined that the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.The returned device review showed no evidence of either the alleged(s) or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a navigator was used during a retrograde intrarenal surgery procedure performed on (b)(6) 2023.During the procedure, a resistance or scraping was felt against the inner wall of the outer sheath when the inner sheath was inserted.The procedure was completed with another navigator device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Additional information received on april 20, 2023: it was reported that the navigator device was used in the ureter during a retrograde intrarenal surgery procedure.

• 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: 16710095
• Report Number: 3005099803-2023-01933
• Device Sequence Number: 7454263
• Product Code: FED
• UDI-Device Identifier: 08714729837558
• UDI-Public: 08714729837558
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 06/16/2023

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: 03/21/2024
• Device Model Number: M0062502260
• Device Catalogue Number: 250-226
• Device Lot Number: 0029088799
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 05/25/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/08/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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