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

Model Number	M0061921530
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
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) 2023.During the procedure, the stent was pushed up as using positioner, the pigtail was buckled, and they failed to insert it.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.A photo of the complaint device was provided and showed that the stent was buckled and torn.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn, inside the patient.Imdrf device code a040601 captures the reportable event of stent buckled, inside the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn, inside the patient.Imdrf device code a040601 captures the reportable event of stent buckled, inside the patient.Update to block g1: manufacturer contact person.Block h10: the returned polaris ultra ureteral stent was analyzed, and a media and visual evaluation noted that the suture hole and tip was torn, also the bladder coil was kinked.Additionally, the positioner was not returned.The suture was returned uncut.Based on the functional inspection, a mandrel 0.039 was loaded into the device and no resistance was felt.No other problems with the device were noted.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 problem, leading to device being kinked and torn.Consequently, affect the performance of the device.For the reported problem of stent buckled material and difficult to advance, they are not confirmed since it was not detected during the analysis.For this reason, the as analyze code will be no problem detected.Therefore, the most probable root cause is adverse event related to the procedure.
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) 2023.During the procedure, the stent was pushed up as using positioner, the pigtail was buckled, and they failed to insert it.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.A photo of the complaint device was provided and showed that the stent was buckled and torn.

• 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: 17980719
• Report Number: 3005099803-2023-05550
• Device Sequence Number: 2467091
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 04/20/2026
• Device Model Number: M0061921530
• Device Catalogue Number: 192-153
• Device Lot Number: 0031474879
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 11/19/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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 Sex: Male