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

Model Number M0061921330

Device Problem Break (1069)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation results of stent detached/separated.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual and magnification evaluation noted that the shaft was detached.Additionally, the suture was not returned.No other problems with the device were noted.The reported event of 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.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 gets entangled in the shaft and is removed using excess force, the stent can get detached during the preparation affecting the performance of the device.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 ureteroscopy procedure in the ureter performed on (b)(6) 2023.During preparation, the stent was found disconnected.It was noted that the stent coil part was snapped or cut into two parts.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.Investigation results revealed that the stent was detached, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the ureter performed on (b)(6) 2023.During preparation, the stent was found disconnected.It was noted that the stent coil part was snapped or cut into two parts.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.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation results of stent detached/separated.Correction to block h10: updated product investigation the returned polaris ultra ureteral stent was analyzed, and a visual and magnification evaluation noted that the shaft was detached.Additionally, the suture was not returned.No other problems with the device were noted.The reported event of 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.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 gets entangled in the shaft and is removed using excess force, the stent can get detached during the preparation affecting the performance of the device.For the reported problem of stent coil detached, it is not confirmed since the detachment of the coil 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.

• 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: 18968737
• MDR Text Key: 338491060
• Report Number: 2124215-2024-16854
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0029112389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 03/25/2022
• 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: 58 YR
• Patient Sex: Female