MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS ULTRA; STENT, URETERAL

Model Number	M0061921430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a polaris ultra stent was returned for evaluation.A visual evaluation of the returned device found that it was damaged at 7cm from the proximal end (bladder pigtail).The suture was not returned for analysis.No other anomalies or damages were encountered.Based on the product analysis, the defect noted could have been caused by the user due to excessive manipulation and interaction of the stent with suture.This type of failure is consistent with one caused when a device is pulled strongly and/or was submitted to an excess of force; excess of force may cause damage, deformities or device break.Therefore, cause traced to component failure, is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was unpacked for use for a ureteral stenting procedure to be performed in the left ureter on (b)(6) 2018.According to the complainant, during preparation, the suture was removed and the stent was noticed to be damaged.It was reported that the stent was damaged by scissors when attempting to remove the suture.The procedure was completed with another polaris ultra stent.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be good.This event has been deemed a reportable event based on the investigation results; stent broken.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8113331
• Report Number: 3005099803-2018-61596
• Device Sequence Number: 2364016
• Product Code: FAD
• UDI-Device Identifier: 08714729124566
• UDI-Public: 08714729124566
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 11/28/2018

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: 10/12/2019
• Device Model Number: M0061921430
• Device Catalogue Number: 63850
• Device Lot Number: 0019815360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR