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

Model Number M0061921420

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat kidney stones during a percutaneous nephrolithotomy procedure in the left ureter performed on (b)(6) 2024.During insertion, it was noted that at the end of the procedure, when the stent was inserted and pushed, it was found kinked.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat kidney stones during a percutaneous nephrolithotomy procedure in the left ureter performed on (b)(6) 2024.During insertion, it was noted that at the end of the procedure, when the stent was inserted and pushed, it was found kinked.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.Update to block d4: expire date 08/09/2026 update to block g2: costa rica block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder tip was buckled.During magnification, it was observed closely that the bladder coil was buckled, tip was torn, and suture hole was torn.No other problems with the device were noted.The reported event was not confirmed.Taking all available information into consideration, most likely, 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 conclude that this problem could be caused by operational factors.Interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess of force applied over the device during the procedure and could have contributed to the failure.For the reported problem of stent kinked, was not detected during the analysis.For this reason, the as analyze code will be no problem detected.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: POLARIS ULTRA
• Type of Device: 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: 18661598
• MDR Text Key: 334792501
• Report Number: 2124215-2024-06180
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 0032188018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male