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

Model Number	M0061921530
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned polaris ultra stent was analyzed, and a visual evaluation noted that shaft was detached at the middle section.The proximal detached section was missing and the suture string was not returned for the analysis.No other problems with the device were noted.The reported event was not confirmed.According to product analysis, the stent was detached at the middle section.The stent returned without the suture string and the device was out of the original pouch, evidence that the stent was manipulated.The problem found is an issue that could have been generated by the user or due to the interacting/handling of the device with the suture string or other devices and incorrect manipulation of the device during procedure and it could have been related to the reported complaint.A 0.35" mandrel was passed through the catheter and no resistance was felt.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral stenting procedure in the right ureter, performed on (b)(6) 2021.During the procedure and inside the patient, when the physician attempted to insert the stent, resistance was felt and there was difficulty in advancing stent.Another polaris ultra ureteral stent used to successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.This event has been deemed a reportable event based on the investigation finding of 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: 11979468
• Report Number: 3005099803-2021-02765
• Device Sequence Number: 3661050
• Product Code: FAD
• UDI-Device Identifier: 08714729720942
• UDI-Public: 08714729720942
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: 11/03/2023
• Device Model Number: M0061921530
• Device Catalogue Number: 192-153
• Device Lot Number: 0026295034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR