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

Model Number	M0061921320
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the polaris ultra ureteral stent was used in a procedure, the lower end of the stent was damaged.Another of the same stent was used to successfully complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Device problem code a0203 captures the reportable event of stent damaged.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device problem code a0203 captures the reportable event of stent damaged.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation found the suture hole torn until the tip.Additionally, the suture and positioner was not returned.Microscopic inspection observed that the suture hole torn until the tip.After the device analysis was found the suture hole torn until the tip, additionally, their suture did not return indicating that it was removed, and the device was used.These failures could have been cause due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during the procedure.Consequently, affect the performance of the device.For that reason, the as analyzed cause code will be "failure to follow instructions." if the suture string/retrieval line is intended to be removed before procedure, the ifu states, the following: retrieval line management options c.The line may be removed before stent placement.The retrieval line may be cut prior to stent placement.Remove the retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull out the retrieval line" according to the time of event, it occurred in the preparation meaning that the suture must have been cut and gently removed, however, the evidence shows the contrary with the found problem.Based on the analysis results, the most probable cause is "failure to follow instructions" since problems traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported that when the polaris ultra ureteral stent was used in a procedure, the lower end of the stent was damaged.Another of the same stent was used to successfully complete the procedure.No patient complications were reported.

• 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: 19943062
• Report Number: 2124215-2024-49235
• Device Sequence Number: 4877052
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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 Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0032984707
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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