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

Model Number	M0061921330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device problem code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during a ureteral dilatation procedure, using a polaris ultra ureteral stent, when the stent was unpacked, it was noticed that the stent was broken along the shaft.Another different stent was used to complete the procedure successfully.No patient complications were reported.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device problem code a0401 captures the reportable event of stent shaft break.Block h10: a visual evaluation of the returned polaris ultra ureteral stent found during the inspection that the stent shaft was detached.Additionally, the positioner and the suture did not return.A media analysis was performed, and a photo is showing a detached stent shaft, moreover, the suture is not visible.During magnification, it was observed closely that the shaft was detached.Therefore, the reported problem of stent shaft detached was confirmed.Based on the most relevant information, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible to concluded that this problem 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 device shaft and is removed using excess force, the stent could be "detached" during the preparation consequently affecting the performance of the device.Moreover, the event mentioned, the damage was found after unpacking during the preparation.The suture of the stent was removed, indicating that the device was manipulated.Based on the analysis results, 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 event.
Event or Problem Description
It was reported that, during a ureteral dilatation procedure, using a polaris ultra ureteral stent, when the stent was unpacked, it was noticed that the stent was broken along the shaft.Another different stent was used to complete the procedure successfully.No patient complications were reported.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: 19602386
• Report Number: 2124215-2024-37394
• Device Sequence Number: 3315045
• 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,Followup
• Report Date (Section B): 10/01/2024

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: 0032117110
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 10/01/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG