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

Model Number	M0062502250
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-01788 for the zero tip¿ stone retrieval basket and manufacturer report# 3005099803-2018-01661 for the navigator ureteral access sheath.It was reported to boston scientific corporation that a navigator ureteral access sheath was used in the ureter during a ureteroscopy with laser lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the zero tip basket was used in conjunction with a ureteral access sheath to capture and remove a stone from the ureter.An attempt to remove the basket with the stone captured through the use of the access sheath was done; however, the basket with the captured stone got stuck in the access sheath.The physician tried to pull the basket out of the access sheath but the attempt was not successful.It was also reported that the stone was too big.The basket with the captured stone, and the access sheath were pulled out from the patient altogether.Once outside the patient, the physician then pulled the basket with the captured stone out of the access sheath successfully.The access sheath was intact but the coating was found peeled off.The procedure was completed with another navigator ureteral access sheath and zero tip basket.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.

• Brand Name: NAVIGATOR¿ HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7568568
• Report Number: 3005099803-2018-01661
• Device Sequence Number: 16772979
• Product Code: FED
• UDI-Device Identifier: 08714729837992
• UDI-Public: 08714729837992
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K122649
• 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
• Report Date (Section B): 05/09/2018

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: 02/06/2020
• Device Model Number: M0062502250
• Device Catalogue Number: 250-225
• Device Lot Number: 21708541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR