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

Model Number M0061921230

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of coil detached, inside the patient.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement via ureteroscopy procedure in the urethra performed on (b)(6) 2023.During the procedure, when they were adjusting the position of the stent after placement, it was found fractured.It was noted that coil part 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 stable.A photo of the complaint device was provided and showed that the coil was detached.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement via ureteroscopy procedure in the urethra performed on (b)(6) 2023.During the procedure, when they were adjusting the position of the stent after placement, it was found fractured.It was noted that coil part 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 stable.A photo of the complaint device was provided and showed that the coil was detached.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of coil detached, inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual, media and microscope evaluation noted that the bladder coil was detached, and the shaft torn.Additionally, the suture was not returned.No other problems with the device were noted.The reported event of coil detached was confirmed.Taking all available information into consideration, most likely, 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 is removed using excess force and entangled in the shaft, the stent can get detached and torn during the procedure, affecting the performance of the device.Consequently, affect 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: 18078800
• MDR Text Key: 327449071
• Report Number: 3005099803-2023-05930
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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: 0029927457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 60 KG