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

Model Number	M0061921330
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft break.Block h11: the polaris ultra ureteral stent was not returned for analysis; however, media is attached within the attachments section of the complaint record and it showed the stent shaft break, additionally, it was possible observed a box of device, the positioner and the suture.The reported event of stent shaft break will be confirmed.It is possible to conclude that this issue could be caused by operational factors, the retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the stent and is removed using excess force, the stent can get detached or separated during the preparation affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that during procedure, when the stent was taken out, it was found that the coil of the tail was broken.The procedure was completed with another of the same device.
Event or Problem Description
It was reported that during procedure, when the stent was taken out, it was found that the coil of the tail was broken.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft break.Block h11: the polaris ultra ureteral stent was returned for analysis.During media and visual inspection, and device inspection under magnification, it was possible to see that the stent shaft was fully detached.Additionally, the suture hole was torn until the tip and the suture was returned tangled and dissambled from the device, indicating it was removed.The reported event of stent shaft break will be confirmed.These failures could have been caused due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during procedure which consequently affects the performance of the device.The labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.Retrieval line options part c states that 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, however, during the analysis it was found the suture hole torn until the tip indicating the suture was removed using excessive force.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions, since problems were traced to the user not following the manufacturer's instructions.

• 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: 21976075
• Report Number: 2124215-2025-28623
• Device Sequence Number: 12550617
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: (01)08714729124443(17)270313(10)33623550
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: M0061921330
• Device Catalogue Number: M0061921330
• Device Lot Number: 0033623550
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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