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

Model Number	M0061552330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during the preparation for the laser lithotripsy procedure, the double coil was found fractured.The procedure was completed with another of the same device.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported that during the preparation for the laser lithotripsy procedure, the double coil was found fractured.The procedure was completed with another of the same device.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the polaris loop stent was returned for analysis.During the microscope and visual inspection, the stent was found with both loops detached.Additionally, the suture did not return.The reported event of stent shaft break will be not confirmed.An additional detachment in the loops was detected that could be related with the reported issue.Regarding to the analysis performed to the returned device, evidence of stent coil detached or 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 get detached during the preparation affecting the performance of the device.Even though the event mentions it occurred when preparing the device for the procedure, the suture of the stent was removed, indicating that the device was manipulated.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 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: 20667805
• Report Number: 2124215-2024-70619
• Device Sequence Number: 17963287
• Product Code: FAD
• UDI-Device Identifier: 08714729421092
• UDI-Public: 08714729421092
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 07/03/2026
• Device Model Number: M0061552330
• Device Catalogue Number: M0061552330
• Device Lot Number: 0031942068
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2023
• 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: Male