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

Model Number	M0062502040
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Initial reporter facility name 1: (b)(6) hospital.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath was used in the right ureter during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2022.During the procedure, the coating on the inner layer of the sheath was peeled off like silk threads and blocked the front view of the lithovue.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block e1: initial reporter facility name 1: (b)(6) hospital.Block h6: imdrf device code a040506 captures the reportable event of sheath peeled.Block h10: investigation result: the returned navigator (sheath and dilator) was analyzed and a visual and microscopic examination found that the inner coating of the sheath was peeled.No other damages were found on the device.With all the available information, boston scientific concludes the reported event was confirmed.It is possible that factors encountered during the procedure, such as operational factors, the interaction/handling with the basket, stones and laser, could cause the problem of sheath peeled.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 was used in the right ureter during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2022.During the procedure, the coating on the inner layer of the sheath was peeled off like silk threads and blocked the front view of the lithovue.The procedure was completed with another navigator access sheath.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16126022
• Report Number: 3005099803-2022-08069
• Device Sequence Number: 17778791
• Product Code: KOD
• UDI-Device Identifier: 08714729429968
• UDI-Public: 08714729429968
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 08/08/2024
• Device Model Number: M0062502040
• Device Catalogue Number: 250-204
• Device Lot Number: 0029917137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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: Male