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

Model Number M0061921230

Device Problem Material Deformation (2976)

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

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopic lithotripsy procedure in the left ureter performed on (b)(6) 2023.During the procedure, when the stent was tried to push for insertion, the stent was deformed.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a0406 captures the reportable event of stent material deformation, inside the patient.Update to block g2: taiwan.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual and microscopic evaluation noted that the bladder coil was deformed, and tip was torn.Additionally, the suture and positioner were not returned.During functional inspection, a mandrel 0.039 was loaded into the device and there was no resistance felt.No other problems with the device were noted.The reported event was 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 pushed up.Excess of force applied over the device during the procedure, could have contributed to the failure, consistently leading to device being torn.Consequently, affect the performance of the device.For the reported problem of stent material deformation, it is possible to conclude that while pulling out the device, the pull could be continuous and using excess of force leading the coil to lose the normal shape, leading the device to be deformed.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.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopic lithotripsy procedure in the left ureter performed on (b)(6) 2023.During the procedure, when the stent was tried to push for insertion, the stent was deformed.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 18540379
• MDR Text Key: 333493770
• Report Number: 2124215-2024-01713
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061921230
• Device Catalogue Number: 192-123
• Device Lot Number: 0031471469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2023
• 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