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

Model Number M0061921330

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/11/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopic lithotripsy procedure in the ureter performed on (b)(6)2023.During the procedure, when the device was unpacked, it was found that the coil was partially broken.It was noted that the coil was detached from the stent.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 good.This event has been deemed a reportable event based on the investigation finding of stent, detached/ separated please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft detached.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the shaft was detached.Additionally, the suture was not returned.During magnification, it was observed closely that the shaft was detached.No other problems with the device were noted.The reported event of stent coil detached 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.Based on the analysis performed, it is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line was removed using excess force, the stent can get detached during the preparation, affecting the performance of the device.Consequently, affects the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.

• 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 ; 5086834015
• MDR Report Key: 18038815
• MDR Text Key: 326964660
• Report Number: 3005099803-2023-05717
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• 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
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0026851189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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