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

Model Number	M006193132090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, found that the proximal section of the stent was damaged (shaft broken at proximal section).The unit returned has residues indicating use and handling.The suture of the device was not present and was not returned for inspection.No other issue was noted.Based on product analysis, it is possible that the way that the device was handled and manipulated may have contributed to the failure found (stent shaft broken).The damage noted is consistent with one caused when the product is being pulled with excess force; this may cause damage or deformities.Therefore, the most probable root cause of this complaint is "adverse event related to procedure" since it is most likely that the adverse event occurred during the procedure and the device had no influence on the event.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 procedure.The event date was not reported.According to the complainant, during preparation, it was noticed that the pigtail was torn.There were no patient complications reported as a result of this event.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.This event has been deemed a reportable event based on the investigation results; stent shaft 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: 8461864
• Report Number: 3005099803-2019-01541
• Device Sequence Number: 3013359
• Product Code: FAD
• UDI-Device Identifier: 08714729762911
• UDI-Public: 08714729762911
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/28/2019

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: 07/22/2021
• Device Model Number: M006193132090
• Device Catalogue Number: 193-132-09
• Device Lot Number: 0022833378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2019
• Initial Report FDA Received Date: 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1