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

Model Number	M0061921430
Medical Device Problem Codes	Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent did not thread with the wire.It was noted that the stent was damaged.The procedure was completed with another of the same stent and no patient complications were reported.Analysis of the returned device identified a stent buckled material.
Additional Manufacturer Narrative
Block b3: date of event was approximated to april 1, 2024, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0203 captures the reportable investigation results of stent buckled material, inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, a visual and magnification evaluation noted that the bladder coil was found with buckled or accordioned.Additionally, the suture was not returned, and the positioner was returned in good condition.During functional inspection, a guide wire of 0.038 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event was confirmed.Taking all available information into consideration, most likely, 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 of force applied over the device during the procedure could have contributed to the failure, consistently leading to device being buckled or accordioned during the preparation or procedure, affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to the procedure since the adverse event occurred during the procedure or preparation, and the device had no influence on event.
Event or Problem Description
It was reported that the stent did not thread with the wire.It was noted that the stent was damaged.The procedure was completed with another of the same stent and no patient complications were reported.Analysis of the returned device identified a stent buckled material.
Additional Manufacturer Narrative
Block b3: date of event was approximated to april 1, 2024, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0203 captures the reportable investigation results of stent buckled material, inside the patient.Updated block h11: the returned polaris ultra ureteral stent was analyzed, a visual and magnification evaluation noted that the bladder coil was found with buckled or according.Additionally, the suture was not returned, and the positioner was returned in good condition.During functional inspection, a guide wire of 0.038 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event was confirmed.Taking all available information into consideration, analysis was performed to the returned device.Evidence of difficult to advance was not confirmed, due the functional test was succeeded when it was done to the device and there was not more evidence related to this kind of reported allegation.Therefore, the cause code will be no problem detected.For the reported event of device damage or defective, 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 of force applied over the device during the procedure could have contributed to the failure, consistently leading to device being buckled or according during the preparation or procedure, affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to the procedure since the adverse event occurred during the procedure or preparation, and the device had no influence on event.

• 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: 19522775
• Report Number: 2124215-2024-34861
• Device Sequence Number: 17696269
• Product Code: FAD
• UDI-Device Identifier: 08714729124566
• UDI-Public: 08714729124566
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 07/28/2025
• Device Model Number: M0061921430
• Device Catalogue Number: 192-143
• Device Lot Number: 0029852956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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