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

Model Number	M0061921210
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report #3005099803-2017-01135 and mfr.Report # 3005099803-2017-01136).It was reported to boston scientific corporation that a polaris ultra stent and an ascerta stent were meant to be used for a cysto stent exchange procedure on (b)(6) 2017.According to the complainant, it was noticed during preparation for the procedure that the inner box containing the sterile device was crumpled on the corner.Reportedly, it was assumed that the sterility of the product was compromised.However, the inner box was not opened to check the sterile pouch containing the device.It is unknown if the outer shipping box was damaged.The device was not used in the procedure, and the procedure was completed with a different device.There were no patient complications reported as a result of this event, and the patient¿s condition at the conclusion of the procedure was reported to be fine.

• 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: 6494661
• Report Number: 3005099803-2017-01135
• Device Sequence Number: 16389050
• Product Code: FAD
• UDI-Device Identifier: 08714729124283
• UDI-Public: (01)08714729124283(17)20170430(10)0016923782
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2017

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: 04/30/2017
• Device Model Number: M0061921210
• Device Catalogue Number: 192-121
• Device Lot Number: 0016923782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1