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

Model Number	M0061921550
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.
Event or Problem Description
It was reported to boston scientific that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the right ureter performed on (b)(6) 2023.During the procedure, when attempted to insert the stent using the positioner, the tail buckled, and it failed to insert.The procedure was successfully completed with another polaris ultra ureteral stent.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: imdrf device code a040601 captures the reportable event of stent buckled material, inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that one picture showed shaft torn, moreover, their positioner was not visible, and the suture was visible.During product analysis, it was observed the shaft buckled or accordion and torn, drainages holes was torn.A functional inspection was performed and a mandrel 0.039" was loaded into the device and no resistance was felt.During magnification, it was observed closely that the device shaft was buckled or accordion, torn, and the drainages holes was torn.No other problems with the device were noted.The reported event of difficult to advance was not confirmed and the reported complaint of stent buckled was confirmed.Taking all available information into consideration, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line was removed using excess force, the stent can get torn during the preparation, affecting the performance of the device and consistently leading to device being buckled and torn.Therefore, the most probable root cause is adverse event related to the procedure.Update to block g1 for manufacturer contact person.
Event or Problem Description
It was reported to boston scientific that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the right ureter performed on (b)(6) 2023.During the procedure, when attempted to insert the stent using the positioner, the tail buckled, and it failed to insert.The procedure was successfully completed with another polaris ultra ureteral stent.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.

• 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 ; 5086834015
• MDR Report Key: 17688271
• Report Number: 3005099803-2023-04579
• Device Sequence Number: 17671291
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/27/2023
• 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