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	02/07/2023
Type of Reportable Event	Malfunction
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 device was used in the urinary tract during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2023.During the procedure, the coating inside the sheath peeled off and a hair-like semi-translucent thread was noticed when the scope was inserted.The procedure was completed with another navigator device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040506 captures the reportable event of sheath peeled.Block h10: investigation result the returned navigator device (sheath and dilator) was analyzed, and a visual evaluation noted that some sort of thread which is part of the inner coating was peeled.Microscopic examination was performed, and it was observed that the inner coating of the device was peeled off at the tip of the sheath.No other problems with the device were noted.The reported event of sheath peeled was confirmed.It is possible that operational factors encountered during the procedure, such as handling and interaction with the devices during use, and/or at the time the devices was passed through the sheath could have caused the reported problem of sheath peeling.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.Block h11: correction: block b5 (describe event or problem) and e1 (initial reporter title and fax number).
Event or Problem Description
It was reported to boston scientific corporation that a navigator access sheath device was used in the urinary tract during a transurethral lithotripsy (tul) procedure performed on (b)(6) 2023.During the procedure, the coating inside the sheath peeled off and a hair-like semi-translucent thread was noticed when the scope was inserted.The procedure was completed with another navigator access sheath.There were no patient complications 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16443340
• Report Number: 3005099803-2023-01026
• Device Sequence Number: 5599583
• Product Code: KOD
• UDI-Device Identifier: 08714729429968
• UDI-Public: 08714729429968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/30/2023

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: 09/20/2023
• Device Model Number: M0062502040
• Device Catalogue Number: 250-204
• Device Lot Number: 0028054092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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