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

Model Number	M006193123090
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	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the polaris ultra ureteral stent had difficulty advancing while being inserted and was found to be in a bellow shape.Another of the same stent was used to successfully complete the procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device codes a040601 and a150205 captures the reportable event of stent buckled material and difficult to advance, inside the patient.
Additional Manufacturer Narrative
Imdrf device codes a040601 captures the reportable event of stent buckled material inside the patient.The returned polaris ultra was analyzed, and a visual evaluation noted that during the inspection it was found that the bladder coil became buckled.Additionally, the suture and positioner did not return.A functional inspection was performed, the mandrel 0.039" was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event was confirmed.Regarding the analysis performed on the returned device, evidence that the bladder coil buckled.It is possible to conclude that this problem could be caused by operational factors, the interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess force applied over the device during the procedure could have contributed to the problem consistently leading to the device being buckled and evidence of difficulty to advance even though it passed the functional test.Therefore, the most probable cause is adverse event related to the procedure.Correction to block h6 in additional mfr.Narrative.
Event or Problem Description
It was reported that during procedure, the polaris ultra ureteral stent had difficulty advancing while being inserted and was found to be in a bellow shape.Another of the same stent was used to successfully complete the procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.

• 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: 20346366
• Report Number: 2124215-2024-60154
• Device Sequence Number: 18128996
• Product Code: FAD
• UDI-Device Identifier: 08714729762867
• UDI-Public: 08714729762867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/27/2024

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: 06/28/2026
• Device Model Number: M006193123090
• Device Catalogue Number: 193-123-09
• Device Lot Number: 0033706012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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: Unknown