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

Model Number	M006192133170
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4).Investigation analysis: a polaris ultra stent was returned for analysis.A visual evaluation of the returned device revealed that no kinks were noted; consequently; not confirming the reported complaint.The suture string was not returned for analysis.Additionally, the returned device was found with the shaft detached near to the renal pigtail section.Based on the product analysis, and all compiled information, the failure found is an issue that could have been generated by the user or due to the interacting 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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra stent was used during a ureteral stent procedure, performed on (b)(6) 2019.According to the complainant, when the product was unpacked, it was noticed that the stent was kinked.The procedure was successfully completed with the use of another polaris ultra stent.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Investigation results revealed the stent shaft was detached, therefore this event has been deemed an mdr reportable event.

• 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: 8705797
• Report Number: 3005099803-2019-03067
• Device Sequence Number: 19385932
• Product Code: FAD
• UDI-Device Identifier: 08714729766520
• UDI-Public: 08714729766520
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 10/30/2021
• Device Model Number: M006192133170
• Device Catalogue Number: 192-133-17
• Device Lot Number: 0023233214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1