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	01/04/2019
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was to be used for a ureteroscopy (urs) procedure, to be performed in the ureter, on (b)(6) 2019.According to the complainant, during preparation, the stent broke in half along the shaft.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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was to be used for a ureteroscopy (urs) procedure, to be performed in the ureter, on (b)(6) 2019.According to the complainant, during preparation, the stent broke in half along the shaft.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.
Additional Manufacturer Narrative
(b)(4).Block h10: investigation analysis: a polaris ultra stent was returned for analysis.A visual evaluation of the returned device found that the stent middle section was broken.The detachment was located in a sideport hole.The suture string was returned properly cut.No other anomalies were noted.Based on the product analysis, the failure found (stent broken) is an issue that could have been generated by the user or due to the interaction of the device with the suture string or other devices used in the same procedure.Therefore, 'adverse event related to procedure' 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.

• 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: 8274690
• Report Number: 3005099803-2019-00269
• Device Sequence Number: 19236622
• 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,Followup
• Report Date (Section B): 03/18/2019

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: 07/15/2021
• Device Model Number: M0061921430
• Device Catalogue Number: 192-143
• Device Lot Number: 0022381127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR