MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER NAVIGATOR¿; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M0062502020
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator ureteral access sheath was used in the ureter during an ureteroscopy and laser lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the inner sheath sheared off.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 fine.
Event or Problem Description
It was reported to boston scientific corporation that a navigator ureteral access sheath was used in the ureter during an ureteroscopy and laser lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the inner sheath sheared off.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 fine.Additional information received on 04apr2018.It was reported that no part of the device was left inside the patient.

• Brand Name: NAVIGATOR¿
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7396848
• Report Number: 3005099803-2018-01023
• Device Sequence Number: 61548
• Product Code: KOG
• UDI-Device Identifier: 08714729429944
• UDI-Public: 08714729429944
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K030956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: 11/19/2017
• Device Model Number: M0062502020
• Device Catalogue Number: 250-202
• Device Lot Number: 18658411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1