MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) POLARIS¿ ULTRA; STENT, URETERAL

Model Number	M006192132090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Renal Failure (2041)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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 an axxcess ureteral catheter that was included in a polaris ultra stent kit was used during an open uterine fibroid procedure performed in the ureter on an unknown date.According to the complainant, during the procedure, the axxcess catheter was used for marking of the ureter and after the procedure of the uterine fibroid, the ureteral catheter was removed.The patient was kept overnight for observation and post procedure, it was reported that the patient experienced a decrease in urination and edema was observed in the ureteral orifice.The patient was diagnosed with postrenal failure and a percutaneous nephrostomy procedure was performed.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an axxcess ureteral catheter that was included in a polaris ultra stent kit was used during an open uterine fibroid procedure performed in the ureter on an unknown date.According to the complainant, during the procedure, the axxcess catheter was used for marking of the ureter and after the procedure of the uterine fibroid, the ureteral catheter was removed.The patient was kept overnight for observation and post procedure, it was reported that the patient experienced a decrease in urination and edema was observed in the ureteral orifice.The patient was diagnosed with postrenal failure and a percutaneous nephrostomy procedure was performed.

• Brand Name: POLARIS¿ ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7704198
• Report Number: 3005099803-2018-02390
• Device Sequence Number: 906710
• Product Code: FAD
• UDI-Device Identifier: 08714729124436
• UDI-Public: 08714729124436
• Combination Product (Y/N): N
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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 Model Number: M006192132090
• Device Catalogue Number: 192-132-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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