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

Model Number	M0061921420
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat kidney stones during a percutaneous nephrolithotomy procedure in the left ureter performed on (b)(6) 2024.During insertion, it was noted that at the end of the procedure, when the stent was inserted and pushed, it was found kinked.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat kidney stones during a percutaneous nephrolithotomy procedure in the left ureter performed on (b)(6) 2024.During insertion, it was noted that at the end of the procedure, when the stent was inserted and pushed, it was found kinked.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.Update to block d4: expire date 08/09/2026.Update to block g2: costa rica.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder tip was buckled.During magnification, it was observed closely that the bladder coil was buckled, tip was torn, and suture hole was torn.No other problems with the device were noted.The reported event was not confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to conclude that this problem could be caused by operational factors.Interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess of force applied over the device during the procedure and could have contributed to the failure.For the reported problem of stent kinked, was not detected during the analysis.For this reason, the as analyze code will be no problem detected.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18661598
• Report Number: 2124215-2024-06180
• Device Sequence Number: 12544871
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: 08714729124542
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 08/09/2026
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 0032188018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male