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

Model Number	M0062502290
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Navigator hd was opened and soaked in water to be used in a ureteroscopy.The hydrophilic coating had rough areas that may have caused damage to the ureter if used.

• Brand Name: NAVIGATOR HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• MDR Report Key: 8357215
• Report Number: 8357215
• Device Sequence Number: 18883580
• Product Code: FED
• UDI-Device Identifier: 08714729839095
• UDI-Public: (01)08714729839095(17)201119(10)22969045
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/15/2019
• Report Date (Section F): 02/15/2019

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: No Information
• Device Model Number: M0062502290
• Device Catalogue Number: M0062502290
• Device Lot Number: 22969045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/15/2019