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

Model Number	M0061921340
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.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 polaris¿ ultra ureteral stent was to be used during a procedure on (b)(6) 2017.According to the complainant, while removing the stent from packaging, it was noticed that the stent was broken in half.The procedure was completed with another polaris¿ ultra ureteral stent.There were no patient complications reported as a result of this event.

• 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: 6588247
• Report Number: 3005099803-2017-01626
• Device Sequence Number: 369791
• Product Code: FAD
• UDI-Device Identifier: 08714729124467
• UDI-Public: (01)08714729124467(17)20190915(10)0019695798
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K010002
• 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): 05/08/2017

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: 09/15/2019
• Device Model Number: M0061921340
• Device Catalogue Number: 192-134
• Device Lot Number: 0019695798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1