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

Model Number	M0061921230
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device problem code a0406 captures the reportable vent of stent buckled.
Event or Problem Description
It was reported that, during a flexible ureteral endoscopic procedure, the front end of the stent became buckled.Another of the same device was used to successfully complete 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 stable.
Additional Manufacturer Narrative
Block h6: device problem code a0406 captures the reportable vent of stent buckled.Block h10: the returned polaris ultra stent was analyzed, and a visual evaluation noted bladder coil buckled.It is possible to concluded 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 could have contributed to the failure, consistently leading to device being buckled.Consequently, affect the performance of the device.Based on the analysis results of stent coil buckled, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that, during a flexible ureteral endoscopic procedure, the front end of the stent became buckled.Another of the same device was used to successfully complete 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 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: 19387752
• Report Number: 2124215-2024-31496
• Device Sequence Number: 6875920
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 10/08/2024
• Device Model Number: M0061921230
• Device Catalogue Number: 192-123
• Device Lot Number: 0028171795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2021
• 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: Unknown