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

Model Number	M0061921320
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	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Block h6: imdrf device code a040601 captures the reportable event of stent buckled, inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a left renal lithotripsy under left ureteroscope procedure in the left kidney performed on (b)(6).2023.During the procedure, when the flexible endoscope was completed, the stent could not be implanted smoothly.It was found that the bladder end of the stent was folded.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 stable.A photo of the complaint device was provided and showed that the stent was buckled.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a left renal lithotripsy under left ureteroscope procedure in the left kidney performed on (b)(6) 2023.During the procedure, when the flexible endoscope was completed, the stent could not be implanted smoothly.It was found that the bladder end of the stent was folded.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 stable.A photo of the complaint device was provided and showed that the stent was buckled.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a040601 captures the reportable event of stent buckled, inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, a visual, media and functional evaluation noted that the bladder coil buckled accordion.Additionally, the suture and positioner were returned.No other problems with the device were noted.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.Based on the analysis, 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, it could have contributed to the problem, consistently leading to device being buckled accordion.For the difficult to advance, the buckled accordion is evidence to conclude that during the procedure, the physician pushed and due to the difficult to advance, the device got buckled accordion.The as analyzed code related to this failure is going to be adverse vent related to procedure.Therefore, the most probable root cause is adverse event related to the procedure.

• 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: 17981113
• Report Number: 3005099803-2023-05551
• Device Sequence Number: 11630530
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/15/2023

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: 10/04/2025
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0030282232
• 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: 11/23/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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: Unknown