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

Model Number	M0062502240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a navigator hd access sheath was used in the ureter during a left ureteroscopy, laser lithotripsy, stone extraction, retrograde pyleogram and ureteral stenting procedure performed on an unknown date.According to the complainant, during the procedure, the right ureter was noted to be torn while passing the access sheath.Procedure was immediately stopped and a stent was placed to treat the ureteral tear.It was also noted that it was the wrong site for the procedure.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.

• 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: 7326905
• Report Number: 3005099803-2018-00679
• Device Sequence Number: 10789267
• Product Code: FED
• UDI-Device Identifier: 08714729838272
• UDI-Public: 08714729838272
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: M0062502240
• Device Catalogue Number: 250-224
• Device Lot Number: 21315031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 65