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

Model Number	M0061921420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 polaris ultra stent was to be used in an unknown procedure on an unknown date.According to the complainant, during unpacking, it was noticed that the stent was broken in half.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual inspection of the returned device revealed that it was separated into two sections.The stent had the shaft broken at 10.5 cm from the distal pigtail.The section that was broken was inspected under magnification, and no smooth surfaces were noticed over the fracture zone, which indicated that the stent was not broken due to mechanical cut, in addition, evidence of excessive force and torsion was noted on the section broken, so it is most likely that the complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, or preparation, so the most probable cause is handling damaged.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was to be used in an unknown procedure on an unknown date.According to the complainant, during unpacking, it was noticed that the stent was broken in half.The procedure was completed with a different device.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: 6798840
• Report Number: 3005099803-2017-02501
• Device Sequence Number: 10797435
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: (01)08714729124542(17)20191209(10)20041059
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: 12/09/2019
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 20041059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1