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

Model Number	M0061921330
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the ureteral lithotomy procedure using a polaris ultra ureteral stent, when the ureteral stent was placed using the guide wire, the guide wire was stuck and could not be withdrawn smoothly.
Additional Manufacturer Narrative
Block h6: device problem code c070601 captures the reportable investigation results of stent bent.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was kinked.Additionally, the suture and positioner did not return.A functional inspection was performed and showed a mandrel 0.039 was loaded into the device and no resistance was felt.During magnification, it was also observed closely that the bladder coil kinked.A media analysis was performed, it was observed the device being placed with the guide wire and showed resistance when tried to withdraw.Based on the product analysis of the bladder coil kinked, 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 kinked.Consequently, affects the performance of the device.Therefore, the as analyzed code will be "adverse event related to procedure".Furthermore, the reported problem of stent delivery system difficult to advance could not be ruled out that some conditions related to the guidewire may have caused the "difficult to advance" problem.In regards the stent, since no resistance was felt, no problem detected is the as analyzed cause code.Therefore, the most probable root cause for this event is "no problem detected" since after functional inspections in the complaint device, it was not possible to identify any evidence the alleged malfunction.

• 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: 20350142
• Report Number: 2124215-2024-60922
• Device Sequence Number: 18148675
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• 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
• Report Date (Section B): 10/02/2024

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: 07/30/2026
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0032120332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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