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

Model Number	M0062502011
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device code (b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a navigation access sheath device was used during ureteroscopy procedure performed on (b)(6) 2022.During the procedure, the inner lining of the access sheath was peeling after a stone was pulled through using a basket.The procedure was completed with another navigator access sheath 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.The returned navigator device was analyzed, and a visual evaluation noted that the sheath bent/kink at the distal end.Microscopic examination was performed and observed closely the bent/kink in the device.Additionally, the inner lining was check under the magnification and was found peeled.No other problems with the device were noted.The reported event was confirmed.It is possible to conclude that operational factors, interaction/handling with the zero tip use during the procedure could have led the reported allegation of sheath peeled and consistently caused the bent/kink that was observed and could affect the performance of the device.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.
Event or Problem Description
It was reported to boston scientific corporation that a navigation access sheath device was used during ureteroscopy procedure performed on (b)(6) 2022.During the procedure, the inner lining of the access sheath was peeling back after a stone basketed in a 1.9f zero tip was pulled through.The procedure was completed with another navigator access sheath device.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: 15639623
• Report Number: 3005099803-2022-05915
• Device Sequence Number: 6373283
• Product Code: KOG
• UDI-Device Identifier: 08714729469575
• UDI-Public: 08714729469575
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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 Model Number: M0062502011
• Device Catalogue Number: 250-201
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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