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

Model Number	M0061921550
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the right ureter, performed on (b)(6) 2022.During the procedure and inside the patient, when the stent was inserted, it was noticed that the stent was crushed and failed to deploy.Another polaris ultra ureteral stent was opened and 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.
Additional Manufacturer Narrative
Medical device problem code a0414 captures the reportable event of stent torn material inside the patient.Medical device problem 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 during a ureteroscopy procedure in the right ureter, performed on december 15, 2022.During the procedure and inside the patient, when the stent was inserted, it was noticed that the stent was crushed and failed to deploy.Another polaris ultra ureteral stent was opened and 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.
Additional Manufacturer Narrative
Block h6: medical device problem code a0414 captures the reportable event of stent torn material inside the patient.Medical device problem code a0406 captures the reportable event of stent kinked inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was buckled/accordion, besides it looked relaxed, and the side port holes were stretched out (deformed).The side port hole of the stent was stretched out.During magnification, it was observed closely that the stent was buckled accordion.The reported event of "stent kinked" was not confirmed, however the complaints "stent torn material" and "stent/delivery system difficult to advance" were confirmed.Based on all the information and the device analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to the event description "when this stent was inserted, it was crushed, and the stent insertion failed".Additionally, their suture did not return, indicating that it was removed, and stent was used.After the device analysis, it was found the bladder coil buckled/accordion, their side port holes stretched out and the suture hole was torn.It is possible to conclude that operational factors, interaction of the excess force during interaction with the guide wire such as their positioner during the setting up of the device could have caused the failures observed.Consequently, those failures could lead to "stent/delivery system.Difficult to advance".For the reported issue "stent kinked" it was not confirmed because a kink was not detected during the analysis and neither a related issue with the reported allegation, additionally, the device was found with buckled/accordion, stretch and torn, not kinked.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.

• 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: 16125430
• Report Number: 3005099803-2022-07962
• Device Sequence Number: 12866108
• Product Code: FAD
• UDI-Device Identifier: 08714729124726
• UDI-Public: 08714729124726
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 01/13/2024
• Device Model Number: M0061921550
• Device Catalogue Number: 192-155
• Device Lot Number: 0026630734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Male