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

Model Number	M0061552220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: device problem code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during an endoscopic ureteroplasty procedure, a polaris loop ureteral stent was used, and it was found fractured.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Event or Problem Description
It was reported that, during an endoscopic ureteroplasty procedure, a polaris loop ureteral stent was used, and it was found fractured.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device problem code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during an endoscopic ureteroplasty procedure, a polaris loop ureteral stent was used, and it was found fractured.Another of the same stent was used to successfully complete the procedure.No patient complications were noted.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device problem code a0401 captures the reportable event of stent shaft break.The returned polaris loop ureteral stent was analyzed, a visual evaluation noted that both loops were detached.The suture was not returned.During magnification, it was observed closely that both loops detached.Based on the product analysis, the reported complaint of stent shaft break was not confirmed, and the as analyzed cause code will be no problem detected since the reported issue was not detected during the analysis.However, it was observed that both loops were detached.Regarding to the analysis performed to the returned device, evidence "stent coil detached/separated".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 is removed using excess force, the stent can be "detached" during the preparation affecting the performance of the device.Even though the event mentions it occurred after unpacking the device during the preparation, the suture of the stent was removed, indicating that the device was manipulated.Therefore, the most probable root cause for this event is "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.

• Brand Name: POLARIS LOOP
• 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: 19750545
• Report Number: 2124215-2024-42831
• Device Sequence Number: 17775230
• Product Code: FAD
• UDI-Device Identifier: 08714729421023
• UDI-Public: 08714729421023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• 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,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 Expiration Date: 07/10/2026
• Device Model Number: M0061552220
• Device Catalogue Number: 155-222
• Device Lot Number: 0031987363
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 09/06/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/30/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: 54 YR
• Patient Sex: Male