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

Model Number	M0061552330
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked.
Event or Problem Description
It was reported that, during laser lithotripsy procedure using a polaris loop stent, it was noticed that during insertion that the stent was kinked and could not cross the stenosis.A different device was used to successfully complete the procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable event of stent kinked.
Event or Problem Description
It was reported that, during laser lithotripsy procedure using a polaris loop stent, it was noticed that during insertion that the stent was kinked and could not cross the stenosis.A different device was used to successfully complete the procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable event of stent kinked.Inside the patient.The returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that there was no damage found.Additionally, the suture and positioner was not returned.During media analysis, one picture showed that the stent shaft was kinked near the loop.A functional inspection was performed, the mandrel 0.039 was loaded into the device and no resistance was felt.No other problems with the device were noted.The reported event of stent material deformation and stent delivery difficult to advance was not confirmed.But a kink was found in the photo attached, after visual, microscope and functional inspections in the returned complaint device, it was not possible to identify any evidence of either the alleged issue(s) or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue.Therefore, all compiled information on this investigation determines that the most probable cause is no problem detected.
Event or Problem Description
It was reported that, during laser lithotripsy procedure using a polaris loop stent, it was noticed that during insertion that the stent was kinked and could not cross the stenosis.A different device was used to successfully complete the procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.

• 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: 19829094
• Report Number: 2124215-2024-44019
• Device Sequence Number: 7374165
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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: M0061552330
• Device Catalogue Number: 155-233
• Device Lot Number: 0033060441
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 09/26/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/04/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG