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

Model Number	192-142
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the suture hole torn and the shaft detached.The suture did not returned only the positioner returned.No other issues with the device were noted.The reported event was not confirmed.According to the product analysis, it is possible that operational factors, interaction of the device with the suture string such as entanglement, manipulation or excess of force applied during it use, could have caused the detached observed.Consequently, affect the performance of the device.In the other hand the report complaint of coil detachment of device or device component cannot be confirmed due to the coil was not detached, for this reason the report issue cannot be confirmed.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 that a polaris ultra ureteral stent was used during a retrograde intrarenal surgery procedure, performed on (b)(6) 2021.During the procedure and inside the patient, when the physician pulled back the suture for stent deployment, it was noticed that the coil of the stent was broken.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13766426
• Report Number: 3005099803-2022-01183
• Device Sequence Number: 14460303
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: 08714729124542
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

1 Device 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: 02/13/2024
• Device Model Number: 192-142
• Device Catalogue Number: 192-142
• Device Lot Number: 0026803872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial